Copy of 2003 Group Newsletter 12 15 - SWOG

Southwest Oncology Group
THE GROUP NEWSLETTER
THE
GROUP
NEWSLETTER
DECEMBER 2004
Operations Office
14980 Omicron Drive, San Antonio, Texas 78245-3217
This is where it is...
Message from the chairman .... Page 1
Priority List on your PDA ....... Page 2
Policy amendment ................... Page 3
Orientation for Chair-Elect ..... Page 3
SWOG Web registrations ........ Page 3
CCRC News ............................. Page 4
Physician Fact Sheets .............. Page 4
Consent translations................ Page 4
Young Investigators ................ Page 5
Quality Assurance Corner ....... Page 5
Plenary Session ........................ Page 6
Statistical Center celebration . Page 7
Crush the Crab results ............. Page 8
CT nurse mentorship............... . Page 9
Manuscripts.............................. Page 11
Abstracts ................................... Page 12
Publications notice.................. Page13
Protocol activations ................ Page 14
Future Group meetings ........... Page 14
Protocol closures ..................... Page 15
Pharmacy Committee .............. Page 15
Membership Nominations ...... Page15
Nurse Oncologist News ........... Page 16
CCRP exam .............................. Page 17
Partnerships for Life ................ Page 18
Serious adverse events ............ Page 18
CRA videos .............................. Page 19
CRA mentorship program ....... Page 20
Group office news .................... Page 21
Thanks to our sponsors ........... Page 21
Hope Foundation drawing ...... Page 22
Holiday schedule ..................... Page 23
Happy Holidays
from all of us
to all of you!
Message from the Chairman
Page 1
Vol. 18, No. 4
PHONE: (210) 677-8808 FAX: (210) 677-0006
INTERNET ADDRESS: http://swog.org
Statistical Center’s 20th anniversary
By Dr. Charles A. Coltman, Jr.
Two years after Larry Baker and I assumed leadership of the Southwest
Oncology Group, the Group Competitive Renewal was due at the National Cancer
Institute on February 1, 1983. The site visit was held in San Antonio on April 24-26, 1983,
and on July 7, 1983, the Southwest Oncology Group grant was approved for funding and
the Southwest Oncology Group Statistical Center was disapproved.
Thus began the saga of the selection of a new statistical center for the Group,
which culminated in the 20 th anniversary celebration at the Southwest Oncology Group
Meeting in Kansas City. On August 29, 1983, a request for applications for a new
statistical center was distributed to academic institutions across the country. All such
applications received would be reviewed by an independent review team, and the
applicant ultimately selected would then submit a grant proposal to the NCI for funding.
The Statistical Center Special Review Committee consisted of the following:
Byron William Brown, Jr., Ph.D.
Robert Friedman, M.D.
Stephen L. George, Ph.D.
Herman E. Mitchell, Ph.D.
Carol Redmond, Sc.D.
Thomas E. Davis, M.D.
Professor Gio Wiederhold
Richard A. Gams, M.D.
Marcello Pagano, Ph.D.
Continued on the next page.
The purpose of THE GROUP NEWS-
LETTER is to facilitate Groupwide
communication.You may submit
articles by mail or e-mail to the
Operations Office to the attention
of the editor, Rosanne Fohn,
(rfohn@swog.org). The deadline
for the February 2005 issue is December
27, 2004. Copyright 2003.
Charles A. Coltman, M.D., celebrates the Southwest Oncology Group Statistical Center’s 20th
anniversary with John J. Crowley, Ph.D. during the plenary session.
DECEMBER 2004

Page 2
THE GROUP NEWSLETTER
Message from the Chairman (Continued from front page)
Bill Brown was the chairman of the committee and
head of the Department of Biostatistics at Stanford University.
Stephen George was the head of Biostatistics at St. Jude’s
Hospital in Memphis, Tennessee. Carol Redmond was the
biostatistician for the National Surgical Adjuvant Breast and
Bowel Project. Professor Gio Wiederhold and Marcello Pagano
were computer scientists, and Drs. Robert Freidman and
Herman Mitchell were data management experts. Tom Davis
and Dick Gams rounded out the team of 10 charged with
reviewing the applications. A total of 10 letters of intent,
followed by five full-blown applications were received.
Following a detailed conference call, the five institutions were
narrowed down to Johns Hopkins University and the Fred
Hutchinson Cancer Research Center. These two centers were
invited to a reverse site visit at the AMFAC Hotel at the Dallas-
Fort Worth Airport. That reverse site visit was held December
19-20, 1984. As it turned out, neither of the applicants was
approved.
At the end of this 14-month process, the unacceptable
or disapproval outcome of both institutions prompted an
embargo of the Special Review Committee until a more
appropriate outcome was reached. The Special Review
Committee identified four requirements which would make the
Fred Hutchinson Cancer Research Center application more
acceptable. January 25, 1985, following a review of the revised
application from the Fred Hutichinson Cancer Research Center,
the Special Review Committee unanimously recommended
that the Fred Hutchison Cancer Research Center, under the
direction of Dr. John J. Crowley, be approved as the new
Statistical Center for the Southwest Oncology Group. On January
The Southwest Oncology Group
priority list of open studies can now be
downloaded to your Palm Pilot, Pocket PC or
other personal digital assistant. The service
is being started at a basic level with just the
priority list for each disease committee,
including open studies by title, drugs, eligible
participating institutions, activation date,
and for each protocol a link to a separate
eligibility criteria page.
Downloads are being provided
through the AvantGo® mobile Internet
service. If you are a regular PDA user, you
may already subscribe to some of the many
AvantGo channels, ranging from news to
entertainment to medical subjects. If so, you
can subscribe to the Southwest Oncology
Group Priority List in the AvantGo Health/
Healthcare Professionals section. But
whether you are a current AvantGo
subscriber or not, the easy way to get
DECEMBER 2004
31, 1985, the Board of Governors unanimously elected John J.
Crowley, Ph.D., as the new Group statistician, authorizing him
to make a formal application to the NCI. The rest is history.
In preparation for the Fall 2004 Group Meeting
Plenary Session recognizing the Statistical Center’s 20 th
anniversary, I communicated with Drs. Brown, George and
Redmond. They unanimously agreed that presentation of
milestones over the past 20 years would be an attractive
opportunity for Group members to hear this special part of the
Group’s history; therefore, presentations were prepared on data
and safety monitoring, person-years saved from therapeutic
trials, the design of the Prostate Cancer Prevention Trial,
statistical considerations for the PCPT Program Project Grant,
the Web-based systems for the accrual of men to the SELECT
prostate cancer prevention trial and finally, a discussion of the
future plans for the Statistical Center.
While the program to honor the Statistical Center had
been kept a secret in order to surprise Dr. Crowley, he finally
was clued in from the agenda that was distributed just before the
plenary session began. What Dr. Crowley also did not know
was that his own employees and former employees had been
preparing presentations and that Drs. Brown, George and
Redmond - members of the infamous Special Review Committee
- would soon walk up to the dais to take part in a panel
discussion about the Statistical Center’s selection and its
progress through the years. Later, the three visitors joined us for
a cocktail party followed by dinner in recognition of the
astonishing accomplishments of the Southwest Oncology
Group Statistical Center.
Open study priority list is now available on your PDA
connected is to go to the PDA Bulletin
Board page on http://swog.org and follow
the prompts.
After you have subscribed to the
Southwest Oncology Group channel and
installed the AvantGo software on your PC,
when you synchronize your PDA the priority
list will automatically be kept up to date for
you. If your PDA has wireless Internet
access, you can visit the PDA version of the
priority list directly by going to http://
swog.org/pda.
Depending on usage, other options
will be added, such as the ability to select
only diseases of interest or protocols
approved by local the local institutional
review board. Meanwhile, contact the
Operations Office with your suggestions,
comments, problems or anything else on
the subject by sending an e-mail to
webmaster@swog.org.

THE GROUP NEWSLETTER
Page 3
Operations Office provides orientation for Chair Elect Dr. Baker
To get a better understanding of how the Southwest
Oncology Group Operations Office supports Group activities,
Chair Elect Laurence Baker, D.O., visited the San Antonio office
for a two-day orientation October 4 and 5. Baker, who will succeed
Group Chairman Charles A. Coltman, M.D., in April 2005, has
served as Associate Chair of the Group since 1981.
During his orientation, Baker heard presentations from
Marjorie Godfrey, Director of the Group’s Operations Office, as
well as all Operations Office department heads regarding protocol
management, accounting, membership, regulatory affairs,
publications, grants, communications, Group meetings, quality
assurance and serious adverse events.
Also accompanying Baker from the University of
Michigan were attorney Anna M. Schork; Denise Reinke, Associate
Director for Sarcoma Research; and Robert Barbret, associate
director of Financial Operations.
When the Group’s leadership changes in April, the
Operations Office will remain in San Antonio and Dr. Baker will
conduct his chairmanship from the Group Headquarters at
DECEMBER 2004
the University of Michigan, while the Group’s Statistical Center
will continue to operate in Seattle.
From left, Anna M. Schork, University of Michigan attorney; Dr.
Charles A. Coltman, Group chairman; Dr. Laurence Baker, chairelect;
Robert Barbret, UM associate director of Financial Operations;
Denise Reinke, UM associate director for Sarcoma Research; and
Marjorie Godfrey, director of the Operations Office.
New amendment outlines ‘lost-to-follow-up’ procedures
During the Fall 2004 Group Meeting, the Board of
Governors approved an amendment to Policy #30, which outlines
institutional responsibility for patient follow-up for Southwest
Oncology Group trials. This change will for the first time define a
formal method to identify a patient as “lost to follow-up (LTF).”
This policy refers mainly to patients on therapeutic trials.
Information about follow up on participants in the SELECT study
will be communicated separately.
In order for the LTF-designation to be approved, an
institution must document the following:
• The institution’s last contact with the patient was at least
two years ago.
• The institution has made three separate attempts to
contact a patient by phone and/or has sent a certified letter which
has either been ignored or returned with addressee unknown.
• The institution has either searched the National Death
Index (NDI) or submitted the patient’s information to the Statistical
Center to be included in a periodic NDI search.
When these requirements are met, the patient will be
designated as “lost to follow-up” in the database and will no longer
IATA training video to be
available soon for check out
Anyone who ships study specimens and was unable to
attend the Continuing Education Workshop for IATA Training
is encouraged to check out the video which will be available
soon. The CRA Committee is working on the details to make
it possible for CRAs to watch the video, then take the certification
exam. More information will be available in the future.
be included in the monthly Expectation and IPR reports. Periodic
lists of LTF-patients will continue to be sent as a reminder in case
data for such a patient becomes available.
The Statistical Center is developing a form to help identify
LTF patients, and a notification will be sent out when it is available
on the CRA Workbench.
The success of Southwest Oncology Group trials continues
to rely on the complete and prompt submission of required materials,
which has helped ensure that the number of patients who are lostto-follow-up
remains small.
SWOG Web registrations
Since the release of the Southwest Oncology
Group Web Registration Program, we have continued
to print and mail confirmations of registrations to
institutions for the registrations CRAs have conducted
on their own.
In addition, we have always recommended
that you save your confirmations and print them once
you are done. However, effective Nov. 1, 2004, we
will no longer mail confirmations for registrations
done at your site using the Web Registration Program.
If you forget to save or print these, you can always
contact the Data Operations Center at (206) 652-2267
to request that a copy be sent to you. Please note that
we will continue to send any confirmations for
registrations that are phoned into the Southwest
Oncology Group Data Operations Center.

Page 4
Cancer Control Research Committee Report
Against the backdrop of Kansas City, already famous for
mouth-watering barbecue and spicy jazz, the Cancer Control
Research Committee held a full day of activities during the fall Group
meeting of the Southwest Oncology Group.
Molecular Epidemiology Committee
First on the day’s agenda was the Molecular Epidemiology
Committee meeting, led by Dr. Regina M. Santella, who summarized
the previous day’s meeting of the entire team of key PCPT P01
investigators. The primary purpose of this meeting was to discuss
the NCI Draft Review Report of the peer review conducted Sept. 7-
9, which included the latest major development of the study. The
next step in the P01 review process is further evaluation by other NCI
review committees in the coming months.
Other items discussed at the Molecular Epidemiology
Committee meeting included:
• Pharmacogenetic/molecular epidemiologic studies,
including the R01-funded studies “Pharmacogenetics: Breast Cancer
Treatment and Prognosis” (SWOG-8897), “Lung Cancer in
Women,” and an ancillary case-control study within the Selenium
and Vitamin E Cancer Prevention Trial (SELECT).
• Research blood specimens of SELECT and PCPT.
• The recently reviewed resubmission of the NCI Program
Project (P01) application, “Biology of the Prostate Cancer Prevention
Trial” which involves several key members of the subcommittee.
Chemoprevention Subcommittee
During the three-hour session led by Dr. Gary E. Goodman,
the subcommittee held major discussions regarding two proposed
new cancer chemoprevention studies that are coming closer to
activation:
• S0300, “Chemoprevention of Breast Cancer with the
Cyclooxygenase-2 Inhibitor Celecoxib: Phase II Trial”
• S0212, “Phase IIb Placebo-Controlled Trial of Oral
Celecoxib for High-Grade Squamous Intraepithelial Lesions of the
Cervix.”
Several other proposals were discussed, including Calcium,
Aspirin and Selenium [CASE] for Preventing Colorectal Cancer and
Polyp Recurrence; Tamoxifen versus Letrozole for Breast Cancer
Prevention; and a study with Selenium in Patients with Barrett’s
Esophagus.
The subcommittee also discussed updates of open studies
including S9917, “L-Selenium-based Chemoprevention of Prostate
Cancer among Men with High-Grade Prostatic Intaepithelial
Neoplasia,” which has an accrual of 317 randomized men, as well as
ongoing matters for the closed SELECT study (S0000).
CCRC Open Meeting
CCRC Chair Dr. Scott M. Lippman convened the threehour
CCRC Open Meeting which featured the keynote address by
Behavioral and Health Outcomes (BAHO) Subcommittee Chair Dr.
Carolyn G. Gotay. Dr. Gotay’s presentation, “Behavioral
Interventions for Preventing Cancer: State of the Science and
Implications for Southwest Oncology Group Research,” discussed
the role of behavioral factors in cancer etiology, theories of behavior
DECEMBER 2004
THE GROUP NEWSLETTER
change, the relationships between tobacco, diet, and physical
activity and cancer.
Next on the agenda was the Harry E. Hynes CCOP
Symposium, chaired by Dr. J. Philip Kuebler, entitled “Cancer
Control Credits and the Southwest Oncology Group.” Panel members
Dr. Lori Minasian, NCI Research Group Chief; Dr. Gotay, BAHO
Subcommittee Chair; Dr. Goodman, Chemoprevention
Subcommittee Chair; and Dr. James L. Wade III, Central Illinois
CCOP PI; briefly summarized their visions of available, feasible
prevention and control studies for CCOP participation. The following
discussion provided outstanding insights into successfully
conducting CCRC research in the CCOP setting.
BAHO Subcommittee
One of the highlights of the BAHO Subcommittee meeting,
chaired by Dr. Gotay, was the good news that S9908, “A Double-
Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of
Glutamine Supplementation Upon Radiation Therapy-Induced Oral
Mucositis in Head and Neck Cancer Patients,” would be re-activated
after solving the drug reconstitution problems that had caused its
temporary closure. More good news was that the NCI has recently
increased the cancer control credit from 0.5 to 1.0 credit for each
protocol registration.
New on the CTSU menu:
Physician Fact Sheets
Over the next several weeks, the Cancer Trials Support
Unit (CTSU) will be posting Physician Fact Sheets for each of the
treatment protocols on the CTSU menu.
Each fact sheet has a summary of the treatment plan and
study population, as well as the study schema. These are intended
for use by healthcare professionals, not as patient education
materials.
You can find Physician Fact Sheets on the Member Web
site under “Education and Training” (soon to be renamed “Education
and Promotions”). Click on “Protocol-Specific Materials.” You
also can find the fact sheets by searching under “Protocol” and then
selecting “Education and Training documents.”
Informed Consent Form translations
The CTSU has announced that Spanish translations will
be done for consent forms on all protocols on the CTSU menu
except those that are close to accrual or when there is an
expectation of accrual closure.
Consents are translated into French when a CTA is
held by NCIC-CTG or another Cooperative Group with Health
Canada.
How to access translated informed consent forms after
accessing the Member area of the CTSU Web site:
1. Click on “Protocols.”
2. Select a protocol by ID number.
3. Choose “Site Registration Documents.”
4. Translated consent forms are listed by language.

THE GROUP NEWSLETTER
Newest Young Investigators
introduced at Group meeting
Four doctors chosen for the fall 2004 Young
Investigators Training Course were honored at the fall Group
meeting after completing two weeks of training in the conduct
of clinical trials in the Southwest Oncology Group. The
physicians spent one week each at the Operations Office and
Statistical Center.
Honored during the plenary session were:
• Anthony B. El-Khoueiry, M.D., clinical instructor
at the University of Southern California, Norris Comprehensive
Cancer Center, whose research is focused on development of
novel therapies for treatment of gastrointestinal cancers,
incorporating parmacokinetics and pharmacodynamics with
pharmacogenomics.
• Omid Hamid, M.D., chief fellow, Medical
Oncology, at the University of Southern California, Los
Angeles County Hospital, who is researching the development
of an effective treatment for advanced or metastatic soft tissue
sarcomas.
• Zeina A. Nahleh, M.D., associate medical director
at the University of Cincinnati Hematology-Oncology Clinic
at University Pointe in West Chester, Ohio, who plans to focus
on male breast cancer.
• Jeffrey B. Smerage, M.D., Ph.D., clinical fellow,
Hematology/Oncology at the University of Michigan, who is
Page 5
Charles A. Coltman, Chairman of the Southwest Oncology Group
(center) with Young Intestigators (from left) Jeffrey B. Smerage, M.D.,
Ph.D.; Zeina A. Nahleh, M.D.; Anthony El-Koureiry, M.D., and Omid
Hamid, M.D.
seeking an appropriate and effective treatment course for
metastatic breast cancer patients.
Since the program began in 2000, 31 investigators have
joined the ranks of seasoned researchers in the Southwest
Oncology Group. Ten protocols have been introduced and
activated at institutions across the United States.
The Young Investigators Training Course is sponsored
by AMGEN through The Hope Foundation.
QA Corner
Want to know how to avoid audit deficiencies
Some study sites are continuing to register patients
to the incorrect institution or investigator. This may result in
being written up for audit deficiencies.
Avoiding an audit deficiency can be as simple as
taking the time to ensure that each patient is registered using
the correct Southwest Oncology Group institution number
for the specific institution or component where the patient
will be treated. This simple error is most often seen with
member components registering patients through their main
member institution code, as well as with CCOP components
registering patients through the “storefront” or main CCOP
code.
In addition to leaving sites open for unnecessary
audit deficiencies, incorrectly registering patients can cause
other problems throughout the Group. Taking the time to
make sure patients are registered correctly will:
• Facilitate IRB approval verifications. IRB
approvals are tracked according to individual institutions;
therefore, if the patient is not registered correctly the
DECEMBER 2004
database verification system for tracking IRB approvals prior
to registration will not function as required.
• Facilitate accrual credit. Registering patients
correctly will ensure that your institution and its respective
investigators are credited with accurate accrual numbers for
payments and grant appropriations, (e.g., Member vs. UCOP).
• Facilitate data collection. For patient follow-up, it
is necessary to know which institution is responsible for each
individual patient in order to facilitate data collection at the
Data Operations Office as well as for ongoing IRB approval
at the responsible institution.
If you are not sure of your site’s SWOG institution
number, please contact the Operations Office at (210) 677-
8808.
Do you have suggestions for future QA topics
Please contact Elaine Armstrong, Southwest Oncology
Group Quality Assurance Manager, at earmstrong@swog.org
or (210) 677-8808.

Page 6
THE GROUP NEWSLETTER
Plenary session celebrates Statistical Center’s 20th anniversary
Under the shroud of secrecy until just before the plenary
session began, the topic of the Southwest Oncology Group’s main
session paid tribute to the many accomplishments and advances of
the Group’s Statistical Center, which is celebrating its 20 th
anniversary this year under the longtime directorship of John J.
Crowley, Ph.D.
Following opening remarks by Group Chairman Dr.
Charles A. Coltman Jr., he and
Chairman Elect Dr. Laurence H.
Baker set the tone with a
lighthearted presentation of the
complicated process used to select
the Statistical Center more than 20
years ago.
Next, several Statistical Center
employees and former employees
gave presentations on the Stat
Center’s many accomplishments.
Among the presenters were:
• Stephanie J. Green, Ph.D., former
Statistical Center statistician who now
Stephanie J. Green,
works for Pfizer Corporation in New
London, Connecticut, spoke about
the Data and Safety Monitoring
Committee.
• Biostatistician Joseph M. Unger, M.S., spoke on the
Person-Years Saved On Therapeutic Trials.
• Phyllis Goodman, M.S., lead statistician for PCPT, spoke
on the Prostate Cancer Prevention Trial Design.
• Cathy M. Tangen, Dr.P.H., coordinating statistician,
spoke on the statistical considerations for the PCPT PO1.
• Jo Ann
L. Hartline, M.P.H.,
project manager for
SELECT, spoke on
SELECT Web-
Based Systems.
• Jacqueline K.
Benedetti, Ph.D.,
the Statistical
Center’s deputy
director, spoke on
The Statistical
Center’s Future.
Jo Ann L. Hartline, M.P.H.
While the first presentation
was underway, three of the
members of the Statistical Center
Special Review Committee, which
helped select the Statistical Center
years ago, filed to the head table,
surprising Crowley and others in
attendance. The committee
members, Byron William Brown
Jr., Ph.D., Stephen L. George,
Joseph M. Unger, M.S. Ph.D., and Carol Redmond, Sc.D.,
commented on each of the
speaker’s topics and praised the accomplishments the Statistical
Center has given to the international cancer research community.
The meeting concluded with an impromptu speech by Dr.
Crowley, who thanked Dr. Coltman, the presenters and special
guests, for the tribute to the Statistical Center.
Southwest Oncology Group Chair Elect Laurence H. Baker, D.O.; Chairman Charles A. Coltman Jr., M.D; John A. Crowley, Ph.D.; Byron William
Brown Jr., Ph.D.; Carol Redmond, Sc.D.; and Stephen L. George, Ph.D.., celebrate the Statistical Center’s 20th anniversary.
DECEMBER 2004

THE GROUP NEWSLETTER
Page 7
Statistical Center celebration continues into the night
The Saturday morning plenary session set the stage for
a day-long celebration of the Statistical Center’s 20th anniversary.
During the cocktail party on Saturday evening, Dr. Charles A.
Coltman Jr. surprised Statistical Center Director Dr. John J. Crowley
by presenting him with a special framed photo entitled, “Double
Rainbow.”
During the presentation, Dr. Coltman compared the
rainbows to Kaplan-Meier survival curves. He said:
“When I saw this beautiful double-rainbow photograph,
I immediately viewed it as a statistical problem. As you well know,
in 17th-century Ireland people became found of referring to the pot
of gold at the end of the rainbow. The statistical challenge presented
by this photograph is how to choose which rainbow to follow to its
end. Knowing your statistical process, I’m sure you will choose the
correct rainbow and follow it to the elusive pot of gold. When you
do, ‘Cave quid dicis, quando, et cui!’ or ‘Beware of what you say,
when and to whom!’”
A special dinner followed, with Dr. Coltman presenting Dr.
Crowley and Dr. Cathy M. Tangen with a plaque to present to
employees at the Statistical Center when they returned to Seattle,
Washington.
Statistical Center Director Dr. John J. Crowley and Dr.Cathy Tangen,
Coordinating Statistician, accept a plaque from Group Chairman Dr.
Charles A. Coltman Jr. on behalf of the Statistical Center staff.
Southwest Oncology Group Chairman Dr.Charles A. Coltman Jr.
presents a double-rainbow photograph to Statistical Center Director
Dr. John A. Crowley during the cocktail party Saturday evening.
Briefs
Alberts receives award of excellence
Dr. David S. Alberts recently received the third
annual AACR- Cancer Research and Prevention Foundation
Award for Excellence in Cancer Prevention Research. Dr.
Alberts is director of Cancer Prevention and Control at Arizona
Cancer Center.
In addition to serving as co-chair of the Gynecologic
Intergroup Committee, he is an active member of the Cancer
Control Research Committee, Committee on Special Populations
and Gastrointestinal Cancer Committee.
Dr. Petrylak’s video well-received
Dr. Daniel P. Petrylak’s presentation, S9916:
Randomized Phase III Trial of docetaxel (D)/estramustine (E)
versus mitoxantrone (M)/prednisone(p) in men with androgenindependent
prostate cancer (AIPCA), is the ninth-mostviewed
presentation on the ASCO Virtual Meeting Web site.
Dr. Petrylak, Principal Investigator at Columbia University,
is a member of the Southwest Oncology Group’s Genitourinary Cancer
Committee and Board of Governors.
10th Annual Clinical Trials Management in
Oncology Training Program
February 28 - March 2, 2005
at City of Hope National Medical Center
Duarte, California
Presented by
City of Hope National Medical Center
Includes lectures for CRAs covering topics from study
design to reporting adverse events, and everything in
between. Hands-on exercises allow you to work interactively
with others in a supportive atmosphere to solve
problems relevant to the lectures heard that day. The goal
is to give you skills to take back to your place of employment,
allowing you to contribute high-quality data and
protocol management to the research process.
For complete information:
http://cratraining.coh.org
Contact: Dina Johnson at 626-256-4673 ext. 62468
DECEMBER 2004

Page 8
THE GROUP NEWSLETTER
Crush the Crab
Rain clouds part for early-morning run in Kansas City
A break in the clouds on the Saturday morning of the fall
Group meeting gave more than 50 dedicated runners the
opportunity to race through the streets of downtown Kansas City
for the Crush the Crab 5K Run. The event took runners through
picturesque Liberty Memorial Park, up hills and down dales,
before finishing at the same location.
Below is the list of winners from this year’s Crush the Crab
run:
Best overall: Roger Wright and Halle Moore.
Men ages 40 and younger: Roger Wright, first place; Peter
Weaver, second place; and Pramod Sharma, third place.
Men ages 41-54: Daniel Hayes, first place; Harry Erba, second
place; and Paul Okunieff, third place.
Men ages 55 and older: Brian Issell, first place; James Bearden,
second place; and Benjamin Marchello, third place.
Women, ages 40 and younger: Halle Moore, first place; Helen
Chew, second place; Cathy Eng, third place.
Women ages 41-54: Peggy Porter, first place; Anita Comley,
second place; and Sandra McKnight, third place.
Women ages 55 and older: Susan Schulman, first place; Julie
Kish, second place; Christine Johnson, third place.
Overall winners Roger Wright and Halle Moore
Winners of the 40 and younger category: Roger Wright, Peter Weaver
and Pramod Sharma.
At left: Peggy Porter, winner of the women’s 41-54 age category and
Benjamin Marchello, third-place winner in the men’s 55 and over
category. Above: Winners of the men’s 41-54 age category are Daniel
Hayes, Harry Erba and Paul Okunieff.
See page 9 for more Crush the Crab winners
DECEMBER 2004

THE GROUP NEWSLETTER
Page 9
An investment in the future
Mentorship program nurtures new clinical trial nurses
By Rose Ermete RN, BSN, OCN, CCRP
The field of oncology clinical trials is ever changing.
Regulations and federal oversight are continually increasing,
while study designs become more and more complex. These
changes contribute to the challenges the nursing profession faces.
Meanwhile, the number of young people entering nursing
continually declines as those already in the profession continues
to age. The field of clinical trials will have to compete with other
specialties to attract - and keep - the best of the best.
Clinical trial nurses (CTN) have varying roles and
responsibilities, based on their location and type of practice. It is
evident that the novice CTN may experience significant role
confusion in attempting to navigate a course through these
unfamiliar waters. And as nurses explore this exciting, and everchanging
field, they will need the support of experienced CTNs
who are willing to pass along their experience and knowledge to
cultivate the professional growth of the novice CTN (Benner,
1984). These experienced nurses are our profession’s legacy. This
investment in new nurses is indeed an investment in the future of
the profession.
The clinical trial nurse mentorship program was launched at
the Fall 2002 Group Meeting with a very positive response. This
program was piloted through the Nurse Oncologist Committee of
the Southwest Oncology Group in collaboration with the ONS
Clinical Trial Nurse Special Interest Group. The program has been
designed to match a mentor with a novice nurse who shares a similar
work environment. This mentorship program is designed to help
new nurses navigate the course through uncharted waters, assisting
in the understanding and development of the various roles that the
clinical trial nurse experiences.
After the completion of the pilot, the findings were presented
to the Group’s Nurse Executive Committee and the CTN SIG of
ONS. It was agreed that a subcommittee should be formed to
implement the suggested changes from the pilot study, as well as
increase both the number and location of mentors.
Mentorship is vital to the growth and professional development
of the oncology clinical trial nurse. Studies have shown that those
who are mentored have greater success in their career and are more
likely to mentor others (Ragins, Cotton & Miller, 2000; Collins
& Scott, 1978; Roshe 1979). Mentorship is grounded in the future
rather than the present or past. Without mentoring there is no
growth in a profession.
Consider passing on your legacy to the clinical trial nurse of
tomorrow. If you are interested in joining the Mentorship
Committee as a mentor or a committee member, please contact
Rose Ermete at rermete1@hfhs.org.
References:
Benner, P. (1984). From Novice to Expert: Excellence and Power
in Clinical Nursing Practice. Menlo Park: Addison-Wesley
Publishing Co.
Collins, E. & Scott, P. (1978). Everyone who makes it has a mentor.
Harvard Business Review, 56 (4) 89 – 101.
Ragins, B. E., Cotton, J. L. & Miller, J. S. (2000). Marginal
mentoring: the effects of type of mentor, quality of relationship,
and program design on work and career attitudes. Academy of
Management Journal, 43, 1177.
Roche, G. (1979). Much ado about mentors. Harvard Business
Review, 57(1) 14 – 16, 20, 24, 26-28.
See next page for Clinical Trials Nurse Mentorship Program Application.
More Winners From The Crush The Crab 5K Run
Winning the women’s 55 and older category were Susan Schulman, first
place; Julie Kish, second place; and Christine Johnson, third place.
DECEMBER 2004
Winners of the women’s 40 and younger category include Halle Moore,
first place; Helen Chew, second place; and Cathy Eng, third place.

Page 10
THE GROUP NEWSLETTER
Clinical Trials Nurse Mentorship Program Application
(Circle) I am requesting a mentor I wish to become a mentee
Name/credentials: ___________________________________________________________________________________
Institution/affiliation: ________________________________________________________________________________
Address: __________________________________________________________________________________________
City: __________________________________________ State: __________________ Zip Code: ___________________
Telephone: ____________________________ Fax: ____________________ E-mail: _____________________________
Mentee: If you would like us to contact your supervisor, provide
the name and contact information:
Could your mentor/mentee visit you at your site of practice
Name: ______________________________________
(Circle) Yes No
Address: ____________________________________
City: _______________________________________
Could you visit your mentor/mentee at their site of practice
State/Zip: ___________________________________
(Circle) Yes No
E-mail: _____________________________________
Best time to contact: ___________________________
_____ Do not contact my supervisor.
Distance willing to travel: ________ miles
Circle the type of institution in which you are employed:
University CCOP Private office Clinic Satellite institution Other
What is your current position
Clinical trial nurse Nurse practitioner CRA Administration Patient care
Other: _____________________________________________________________________________________
Time in current position: ______________
Time involved in clinical trials: ______________
Circle the areas in which you would like support (protégé) or have experience (mentor):
Audit preparation
Maintaining source documentation
Coordinating a research team
Managing satellite institutions
Budgeting
Patient education
Drug accountability
Patient monitoring
Educating staff/staffing issues
Organizing records/source documentation
Institutional Review Board issues
Recruiting/informed consent/eligibility
Maintaining long-term follow up
Toxicity reporting
Other support areas: __________________________________________________________________________
___________________________________________________________________________________________
Circle the type of trials in which you are involved:
Nursing research Cooperative Group Pharmaceutical Prevention
Treatment Investigator initiated Phase I Phase II & III
Phase IV Other: ___________________________________
Send application to:
CTN Mentorship Program
c/o Rose Ermete
9820 Levan
Livonia, MI 48150
rermete1@hfhs.org
FAX: 313-916-8270
If you work with cooperative group trials, circle the groups with which you are affiliated:
SWOG ACOS CALGB COG CTSU ECOG GOG NSABP NCCTG NCIC NWTSG RTOG
Other: ______________________________
Please list some interests you enjoy outside of work: _______________________________________________________
DECEMBER 2004

THE GROUP NEWSLETTER
Page 11
Published
August 10, 2004 – October 27, 2004 Manuscripts
The publications listed below are those that have been received in published form by the Operations Office Publications
Specialist from August 10 through October 27, 2004.
Manuscripts Published
8710 Pathologic evaluation of radical cystectomy specimens. A Cooperative Group report. HW Herr, JR Faulkner,
HB Grossman, ED Crawford. Cancer 100(11):2470-2475, 2004.
8809 Follicular lymphoma international prognostic index. P Solal-Celigny, P Roy, P Colombat, J White, JO Armitage,
R Arranz-Saez, WY Au, M Bellei, P Brice, D Caballero, B Coiffier, E Conde-Garcia, C Doyen, M Federico, RI
Fisher, JF Garcia-Conde, C Guglielmi, A Hagenbeek, C Haioun, M LeBlanc, AT Lister, A Lopez-Guillermo, P
McLaughlin, N Milpied, P Morel, N Mounier, SJ Proctor, A Rohatiner, P Smith, P Soubeyran, H Tilly, U Vitolo,
PL Zinzani, E Zucca, E Montserrat. Blood 104(5):1258-1265, 2004.
8819 Allelic loss during progression of follicular lymphoma. S Takeuchi, S de Vos, N Takeuchi, AC Fermin, TM
Grogan, H Seo, JW Said, HP Koeffler. Leukemia Research 28:567-569, 2004.
8819 Loss of MHC class II gene and protein expression in diffuse large B cell lymphoma is related to decreased tumor
immunosurveillance and poor patient survival regardless of other prognostic factors: a follow-up study from
the leukemia and lymphoma molecular profiling project. L Rimsza, RA Roberts, TP Miller, JM Unger, M LeBlanc,
R Braziel, DD Weisenburger, WC Chan, K Muller-Hermelink, ES Jaffe, RD Gascoyne, E Campo, D Fuchs, CM
Spier, RI Fisher, J Delabie, A Rosenwald, LM Staudt, T Grogan. Blood 103(11):4251-4258, 2004.
8819 Molecular diagnosis of primary mediastinal B cell lymphoma identifies a clinically favorable subgroup of
diffuse large B cell lymphoma related to hodgkin lymphoma. A Rosenwald, G Wright, K Leroy, X Yu, P Gaulard,
RD Gascoyne, WC Chan, T Zhao, C Haioun, TC Greiner, DD Weisenburger, JC Lynch, J Vose, JO Armitage,
EB Smeland, S Kvaloy, H Holte, J Delabie, E Campo, E Montserrat, A Lopez-Guillermo, G Ott, HK Muller-
Hermelink, JM Connors, R Braziel, TM Grogan, RI Fisher, TP Miller, M LeBlanc, M Chiorazzi, H Zhao, L Yang,
J Powell, WH Wilson, ES Jaffe, R Simon, RD Klausner, LM Staudt. Journal of Experimental Medicine 198(6):851-
862, 2003.
8949 Cytoreductive nephrectomy in patients with metastatic renal cancer: a combined analysis. RC Flanigan, G
Mickisch, R Sylvester, C Tangen, H Van Poppel, ED Crawford. Journal of Urology 171:1071-1076, 2004.
9061 Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell
transplantation in high-risk breast cancer. MS Tallman, R Gray, NJ Robert, CF LeMaistre, CK Osborne, WP
Vaughan, WJ Gradishar, TM Pisansky, J Fetting, E Paietta, HM Lazarus. New England Journal of Medicine
349(1):17-26, 2003.
9107 A phase II pilot study of high-dose 24-hour continuous infusion of 5-FU and leucovorin and low-dose PALA
for patients with colorectal cancer. A Southwest Oncology Group study. RP Whitehead, JK Benedetti, JL
Abbruzzese, B Ardalan, S Williamson, ER Gaynor, SP Balcerzak, JS Macdonald. Investigational New Drugs
22:467-473, 2004.
9201 Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. AA
Forastiere, H Goepfert, M Maor, TF Pajak, R Weber, W Morrison, B Glisson, A Trotti, JA Ridge, C Chao, G
Peters, DJ Lee, A Leaf, J Ensley, J Cooper. New England Journal of Medicine 349(22):2091-2098, 2003.
9201 Outcome of salvage total laryngectomy following organ preservation therapy. The Radiation Therapy
Oncology Group trial 91-11. RS Weber, BA Berkey, A Forastiere, J Cooper, M Maor, H Goepfert, W Morrison,
B Glisson, A Trotti, JA Ridge, KS Clifford Chao, G Peters, DJ Lee, A Leaf, J Ensley. Arch Otolaryngol Head
Neck Surg 129(1):44-49, 2003.
9217 The person-years saved model and other methodologies for assessing the population impact of cancerprevention
strategies. JM Unger, M LeBlanc, IM Thompson, CA Coltman, Jr. Urologic Oncology: Seminars
and Original Investigations 22:362-368, 2004.
9303 Phase III study of adjuvant chemotherapy and radiation therapy compared with chemotherapy alone in the
surgical adjuvant treatment of colon cancer: results of Intergroup protocol 0130. JA Martenson Jr, CG Willett,
DJ Sargent, JA Mailliard, JH Donohue, LL Gunderson, CR Thomas Jr, B Fisher, AB Benson, R Myerson, RM
Goldberg. Journal of Clinical Oncology 22(16):1-7, 2004.
Continued on the next page.
DECEMBER 2004

Page 12
THE GROUP NEWSLETTER
Manuscripts Published (Continued)
9326 Long-term follow-up of a phase II trial of oral altretamine for consolidation of clinical complete remission in women with
stage III epithelial ovarian cancer in the Southwest Oncology Group. DS Alberts, C Jiang, PY Liu, S Wilczynski, M
Markman, ML Rothenberg. International Journal of Gynecologic Cancer 14:224-228, 2004.
9403 A phase II study of 13-cis retinoic acid plus interferon a-2a in advanced stage penile carcinoma: an Eastern Cooperative
Oncology Group study (E3893). RT Skeel, J Huang, J Manola, G Wilding, R Dreicer, P Walker, F Muggia, ED Crawford,
JP Dutcher, PJ Loehrer. Cancer Investigation 21(1):41-46, 2003.
9515 Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell of the head and neck. JS Cooper,
TF Pajak, AA Forastiere, J Jacobs, BH Campbell, SB Saxman, JA Kish, HE Kim, AJ Cmelak, M Rotman, M Machtay, JF
Ensley, C Chao, CJ Schultz, N Lee, KK Fu. New England Journal of Medicine 350(19):1937-1944, 2004.
S9806 Randomized phase II trial of sequential chemotherapy in advanced non-small cell lung cancer (SWOG 9806): carboplatin/
gemcitabine followed by paclitaxel or cisplatin/vinorelbine followed by docetaxel. MJ Edelman, JI Clark, K Chansky, K
Albain, N Bhoopalam, GR Weiss, JK Giguere, K Kelly, J Crowley, DR Gandara. Clinical Cancer Research 10:5022-5026,
2004.
S0004 Phase I study of tirapazamine plus cisplatin/etoposide and concurrent thoracic radiotherapy in limited stage small cell
lung cancer (S0004): a Southwest Oncology Group study. QT Le, J McCoy, S Williamson, J Ryu, LE Gaspar, M Edelman,
S Dakhil, SD Sides, JJ Crowley, DR Gandara. Clinical Cancer Research 10:5418-5424, 2004.
JMA17 A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast
cancer. PE Goss, JN Ingle, S Martino, NJ Robert, HB Muss, JM Piccart, M Castiglione, D Tu, LE Shepherd, KI Pritchard,
RB Livingston, NE Davidson, L Norton, EA Perez, JS Abrams, P Therasse, MJ Palmer, JL Pater. New England Journal
of Medicine 349(19):1793-1802, 2003.
Multiple A new staging system for multiple myeloma patients based on the Southwest Oncology Group (SWOG) experience. JL
Studies Jacobson, MA Hussein, B Barlogie, BGM Durie, JJ Crowley. British Journal of Haematology 122:441-450, 2003.
Multiple Cholesterol synthesis and import contribute to protective cholesterol increments in acute myeloid leukemia cells. DE
Studies Banker, SJ Mayer, HY Li, CL Willman, FR Appelbaum, RA Zager. Blood 104(6):1816-1824, 2004.
None
Overview of non-Hodgkin’s lymphoma: biology, staging, and treatment. RI Fisher. Seminars in Oncology 30(2) Suppl
4:3-9, 2003.
Abstracts Published
8819 Downregulated antioxidant defense enzyme expression is correlated with poor survival in DLBCL. DB Johnson, ME
Tome, LM Rimsza, RA Roberts, W Browne, TM Grogan, TP Miller, MM Briehl. Federation of American Societies for
Experimental Biology 18(5):A953 (#626.6), 2004.
8819 Molecular diagnosis of primary mediastinal B cell lymphoma identifies a clinically favorable subgroup of diffuse large
B cell lymphoma related to Hodgkin lymphoma. A Rosenwald, G Wright, K Leroy, X Yu, P Gaulard, RD Gascoyne, WC
Chan, T Zhao, C Haioun, TC Greiner, DD Weisenburger, JC Lynch, JM Vose, JO Armitage, EB Smeland, S Kvaloy, H Holte,
J Delabie, E Campo, E Montserrat, A Lopez-Guillermo, G Ott, K Muller-Hermelink, JM Connors, R Braziel, TM Grogan,
RI Fisher, TP Miller, M LeBlanc, M Chiorazzi, H Zhao, L Yang, J Powell, WH Wilson, ES Jaffe, R Simon, RD Klausner,
JM Staudt. Blood 102(11):#208, 2003.
9008 Postoperative combined radiation and chemotherapy improves disease-free survival (DFS) and overall survival (OS) in
resected adenocarcinoma of the stomach and gastroesophageal junction: update of the results of Intergroup study INT-
0116 (SWOG 9008). JS Macdonald, S Smalley, J Benedetti, N Estes, DG Haller, JA Ajani, LL Gunderson, M Jessup,
JA Martenson. American Society of Clinical Oncology Gastrointestinal Cancers Symposium #6, 2004.
*9446 Isotretinoin effects on head and neck cancer recurrence and second primary tumors. F Khuri, JJ Lee, SM Lippman, ES
Kim, JS Cooper, SE Benner, EE Vokes, TF Pajak, H Goepfert, WK Hong. Proc of the American Society of Clinical Oncology
22:90 (#359), 2003.
*9446 Longterm adherence, toxicity, and dose-intensity in a head and neck chemoprevention trial. JJ Lee, ES Kim, FR Khuri,
RM Chamberlain, L Feng, B Williams, K Fu, J Cooper, SM Lippman, WK Hong. Proc of the American Society of Clinical
Oncology 22:91 (#364), 2003*9446
*Presented
Continued on the next page.
DECEMBER 2004

THE GROUP NEWSLETTER
Page 13
Abstracts Published (Continued)
*9946 Prognostic factors in early stage head and neck squamous cell carcinoma (HNSCC) patients in a prospective clinical trial.
ES Kim, J Lee, L Fen, S Lippman, G Shenouda, I Hodson, E Vokes, F Khuri, WK Hong. Proc of the American Society of
Clinical Oncology 23:490 (#5515), 2004.
S9917 Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial
neoplasia. Preliminary analysis of Southwest Oncology Group study S9917. WA Sakr, JR Faulkner, D Wood, I Thompson,
D Crawford, S Lippman, C Coltman, J Marshall. Proc of the American Association for Cancer Research 45:305 (#1333),
2004.
*S0000 Introducing HIPAA: triple the cost and triple the time for patient recruitment to the SELECT study. NS Gorby, MS Wolf,
CL Bennett. Proc of the American Society of Clinical Oncology 23:519 (#6009), 2004.
S0003 Hypoxia-related markers in the plasma of patients with advanced non-small cell lung cancer (NSCLC) and survival from
chemotherapy: Southwest Oncology Group (SWOG) S0003. IV Galvin, PN Lara, Q Le, K Chansky, JJ Crowley, S
Williamson, DR Gandara, PH Gumerlock. Proc of the American Society of Clinical Oncology 23:649 (#7146), 2004.
S0101
*Presented
SWOG 0101: Evaluation of gemcitabine and irinotecan in esophageal cancer: SK Williamson, S McCoy, JL Abbruzzese.
American Society of Clinical Oncology Gastrointestinal Cancers Symposium #25, 2004.
S0119 SWOG S0119: a phase II study of gemcitabine and irinotecan for patients with untreated extensive stage small cell lung
cancer (SCLC). WL Akerley, J McCoy, P Hesketh, J Crowley, L Kaye, D Gandara. Proc of the American Society of Clinical
Oncology 23:663 (#7202), 2004.
*N9741 Insulin-like growth factor-I (IGF-1), IGF binding protein-3 (IGFBP-3), and outcome in metastatic colorectal cancer (CRC):
results from Intergroup Trial N9741. C Fuchs, M Pollak, DJ Sargent, JA Meyerhardt, RK Ramanathan, S Williamson, B
Findlay, E Green, RM Goldberg. Proc of the American Society of Clinical Oncology 23:250 (#3521), 2004.
*N9741 N9741: FOLFOX (oxaliplatin(oxal)/ 5-fluorouracil (5-FU)/leucovorin(LV) or reduced dose R-IFL (CPT-11 + 5-FU/LV) in
advanced colorectal cancer (CRC): final efficacy data from an intergroup study. RM Goldberg, DJ Sargent, RF Morton,
C Fuchs, RK Ramanathan, SK Williamson, BP Findlay, HR Pitot, SR Alberts. Proc of the American Society of Clinical
Oncology 23:275 (#3621), 2004.
*N9741 Preliminary evidence of relationship between genetic markers and oncology patient quality of life (QOL). JA Sloan, H
McLeod, D Sargent, X Zhao, C Goldberg. Proc of the American Society of Clinical Oncology 23:2 (#5), 2004.
Multiple Gene expression profiling of adult acute myeloid leukemia identifies novel biologic clusters associated with clinical
Studies characteristics and outcome. C Wilson, M Mosquera-Caro, S Martin, G Davidson, Y Xu, K Ar, J Potter, IM Chen, D Pauler,
H Gundacker, M Slovak, F Appelbaum, K Kopecky, C Willman. Blood 102(11): #602, 2003.
None Editorial: Seminars in Oncology. RI Fisher. Seminars in Oncology 30(2) Suppl 4:1-2, 2003.
Important notice regarding publications
Please remember to share the current status for all
Southwest Oncology Group publications with the Publications
Specialist at the Operations Office, whether they are abstracts or
manuscripts, published or submitted. One of the primary
responsibilities of the Southwest Oncology Group is to report the
results of completed trials. All studies, whether the results were
positive or negative, must be published to assure continued funding
of Group activities by the National Cancer Institute. Therefore,
keeping this information up to date is of paramount importance.
All phases of the publication process with a journal or
society meeting should be reported to the Operations Office. This
includes submissions, resubmissions, acceptances, acceptances
pending revisions, as well as publications not accepted. This will
ensure that complete and accurate publication information is reported
on all Group studies for grant and progress report submissions, in
all newsletters published by the Group, and on the Group Web page.
It will also ensure that investigators and their respective institutions
are correctly credited for the various stages of publication on their
Investigator Contribution Sheets.
Copies of submissions or correspondence received from
the journal can be faxed to the Operations Office at 210-677-0006 or
e-mailed to bgranados@swog.org
DECEMBER 2004

Page 14
THE GROUP NEWSLETTER
Southwest Oncology Group Protocol Update from August 15 — November 1, 2004 Mailings
This PROTOCOL UPDATE serves as reference for protocol activity during the stated period. When noting Temporary Closures and Reactivated Protocols, bear in mind
that temporarily closed studies are often reopened after observation of some degree of antitumor activity in the initial cohort of patients. Other reasons for reopening studies could
include revision of the protocol to enhance the margin of safety for patients or resolution of administrative problems, such as with drug supply or drug distribution. If you have
any questions about a temporary closure or reactivation, you may wish to contact the Study Coordinator for more information.
ACTIVATIONS
S9811
S0301
S0325
S0229
Phase II Study of Hydroxyurea For Unresectable
Meningioma. Study Coordinators: Drs. L. Swinnen and
G. Barger. Reactivation (effective 8/3/04).
A Phase II Study of Induction With Daunorubicin,
Cytarabine, and Cyclosporine All By Continuous IV
Infusion for Previously Untreated Non-M3 Acute
Myeloid Leukemia (AML) in Patients of Age 56 or Older.
Study Coordinators: Drs. T.R. Chauncey, A.F. List, C.L.
Willman, M.L. Slovak and D.R. Head. Reactivation
(effective 8/15/04).
A Phase IIb Study of Molecular Responses to Imatinib
at Standard or Increased Doses for Previously Untreated
Patients With Chronic Myelogenous Leukemia (CML)
in Chronic Phase. Study Coordinators: Drs. B.J. Druker,
M.L. Slovak, and J.P. Radich. Activation (8/15/04).
A Randomized Trial Assessing the Effects of Exercise
on Patients with Locally Advanced Non-Small Cell Lung
Cancer (NSCLC) Undergoing Curative Intent Combined
Modality Therapy (Ancillary to S0023). Study
Coordinators: Drs. A.J. Wozniak, C.C. Gotay, A.L.
Schwartz, K.S. Albain, K. Kelly and R. Chaplan, R.N.,
M.S.N. Activation (9/1/04).
S0412 A Phase II Study of the RAF-Kinase Inhibitor BAY 43-
9006 (NSC-724772, IND-69,896) in Combination with
Interferon Alpha 2b in Patients with Advanced Renal
Cancer. Study Coordinators: Drs. C.W. Ryan, T.M. Beer
and P.H. Gumerlock.Activation (9/1/04).
S0341
Phase II Trial of OSI-774 (NSC-718781) in Patients with
Advanced Non-Small Cell Lung Cancer and a
Performance Status of 2. Study Coordinators: Drs. P.J.
Hesketh, A.J. Wozniak and P.H. Gumerlock.Activation
(9/15/04).
S0356 Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and
Radiation for Potentially Curable Esophageal Cancer: A
Phase II Trial with Molecular Correlates. Study
Coordinators: Drs. L.P. Leichman, C.R. Thomas, Jr., K.G.
Billingsley, T.J. Watson, H.J. Lenz, and C.M. Fenoglio-
Preiser. Activation (9/15/04).
S0432
Phase II Studies of Two Different Schedules and Two
Different Doses of the Farnesyl Transferase Inhibitor
R115777 (Tipifarnib, Zarnestra ® , NSC-702818) for
Previously Untreated Acute Myeloid Leukemia (AML)
in Patients of Age 70 or Older. Study Coordinators: Drs.
H. Erba, C. Willman and M. Slovak. Activation. (9/15/
04).
CTSU/E2902 A Phase III Randomized Study of Farnesyl Transferase
Inhibitor R115777 in Acute Myeloid Leukemia (AML)
Patients in Second or Subsequent Remission or in
Remission after Primary Induction Failure. Southwest
Oncology Group Study Coordinator: Dr. F.R.
Appelbaum. Activation (10/1/04),
S9908
S0420
S0224
S0232
S0415
S0300
A Double-Blind, Placebo-Controlled Trial to Study the
Efficacy and Safety of L-Glutamine (in AES0014 Delivery
Vehicle) Upon Radiation Therapy-Induced Oral
Mucositis in Head and Neck Cancer Patients, Phase III.
Study Coordinators: Dr. V.S. Klimberg. Reactivation -
Amendment #2(10/1/04).
Phase II Evaluation of BAY 43-9006 (NSC-724772) in
Patients with Recurrent or Metastatic Head and Neck
Cancer. Study Coordinators: S. Williamson and C.H.
Huang. Activation (10/1/04).
Phase II Study of Weekly Docetaxel in Patients with
Advanced Epidermoid Carcinoma of the Penis. Study
Coordinators: Drs. T.M. Beer, C.W. Ryan and D.J.
Culkin. Activation (10/15/04).
Double-Blinded Placebo Controlled Phase III Trial
Comparing Dexamethasone (DEX) to the Combination
of DEX + CC-5013 in Patients with Newly Diagnosed
Multiple Myeloma. Study Coordinators: Drs. J.A.
Zonder and B. Barlogie. Activation (effective 11/1/04),
Cetuximab as a Second Line Therapy in Patients with
Metastatic Esophageal Cancer – Phase II. Study
Coordinators: Drs. P. Gold and S. Iqbal. Activation (10/
10/04).
Randomized Placebo-Controlled Biomarker Modulation
Trial using Celecoxib in Premenopausal Women at High
Risk for Breast Cancer. Study Coordinators: Drs P.H.
Brown, G.T. Budd, J. Gralow, K.S. Albain, A.M. Gown
and K. Powell. Activation (11/1/04).
Future Group Meetings
2005
— April 6 - 10, 2005 —
Denver, Colorado
— September 28 - October 2, 2005 —
New Orleans, Lousiana
2006
— April 19 - 23, 2006 —
Salt Lake City, Utah
— October 4 - 8, 2006 —
Seattle, Washington
2007
— May 2 - 6, 2007 —
Chicago, Illinois
— October 3 - 7, 2007 —
Huntington Beach, California
DECEMBER 2004

THE GROUP NEWSLETTER
Page 15
CLOSURES
G0182 A Phase III Randomized Trial of Paclitaxel and Carboplatin
Versus Triplet or Sequential Doublet Combinations in
Patients With Epithelial Ovarian or Primary Peritoneal
Carcinoma. Southwest Oncology Group Study
Coordinator: Dr. D.S. Alberts. Permanent Closure
(effective 9/1/04).
SWOG-9444 Gastrointestinal Tumor Repository Protocol,
Ancillary. Study Coordinators: Drs. C.M.
Fenoglio-Preiser, G.N. Stemmermann, A.E.
Noffsinger and P. Hurtubise.Permanent
Closure (effective 9/1/04).
S0303 A Phase III Trial of Modified FOLFOX6 versus
CAPOX, with Bevacizumab (NSC-704865) or Placebo,
as First-Line Therapy in Patients with Previously
Untreated Advanced Colorectal Cancer. Study
Coordinator: Dr. C. Blanke. Permanent Closure
(effective 9/1/04).
S0317 A Phase II Study of OSI-774 (NSC-718781) in Patients
With Locally Advanced or Metastatic Papillary
Histology Renal Cell Cancer. Study Coordinators: Drs.
M.S. Gordon and P.N. Lara Jr. Temporary Closure
(effective 9/1/04).
S0327 A Phase II Trial of PS-341 (NSC-681239) in Patients with
Platinum-Treated Extensive Stage Small Cell Lung
Cancer. Study Coordinators: Drs. P.N. Lara, Jr., A.M.
Davies, P.H. Gumerlock and W.A. Franklin. Permanent
Closure (effective 9/15/04).
S0207 A Phase II Study of Arsenic Trioxide in Male Patients
with Refractory Germ Cell Malignancies. Study
Coordinators: Drs. T.M. Beer and C.R. Nichols.
Temporary Closure (effective 10/1/04), Sent to All
Southwest Oncology Group Member, CCOP, UCOP and
Affiliate Medical Oncologists and Surgeons.
S0339 Phase II Trial of Gemcitabine, Carboplatin and PS-341
(NSC-681239) in the First-Line Treatment of Advanced
Non-Small Cell Lung Cancer (NSCLC). Study
Coordinators: Drs. A. Davies and P.N. Lara, Jr.Permanent
Closure (effective 10/1/04), Sent to All Southwest
Oncology Group Member, CCOP and Affiliate Medical
Oncologists.
S0108 Bevacizumab (rhuMAb VEGF) (NSC-704865) Therapy
for Patients With Relapsed Aggressive Non-Hodgkin’s
Lymphoma. Study Coordinators: Drs. A. Stopeck, T.
Miller, & T. Grogan; W. Bellamy, R.Ph. Permanent
Closure (effective 12/1/04).
Pharmacy Committee sees increase in membership
A significant increase in Pharmacy Committee
membership was noted at the fall Group meeting. The committee
welcomes new members Barbara Couldry, University of Kansas;
and Sharon Denison and Oscar Martin, both from City
of Hope.
During the meeting Pharmacy Committee
member Gerry Migaki, RPH, gave a lecture at the CRA
training session and participated with committee
member Matt Boron in a round table discussion. Siu-
Fun Wong, Pharm.D., delivered a lecture, “Evolution of
the Taxanes,” at the CRA plenary session and “Antisense
Therapy in Melanoma” during the Nurse Oncologist workshop.
The drug information subcommittee continues to develop
and revise drug information sections and drug monographs. The
Pharmacy Co-op group is organizing the existing drug monographs
DECEMBER 2004
available from ECOG, COG, GOG, and SWOG to formulate a single
collection of drug monographs. The committee expects to complete
this work within one to two years. The committee welcomed Gilland
Dea, Pharm.D., from University of California-Davis to be
the pharmacist liaison of the Lung Cancer Committee.
The Pharmacy Committee continues to evaluate
and develop proposals for a pharmacy-initiated research
project. Several proposals were discussed at the
committee meeting. Pharmacy Committee members are
encouraged to come to the next meeting and participate
in concept development.
Please continue to encourage any pharmacist working in
oncology research to apply to the Pharmacy Committee. For more
information, please contact Pharmacy Committee Chair Siu-Fun
Wong at siuwong@westernu.edu.
March 11 next deadline to submit membership nominations
The next deadline for submitting membership
nominations to the Operations Office is March 11, 2005. Prior to
each Group meeting nominations are considered for Member,
CCOP, Affiliate, UCOP and Special Member investigators.
Nominations are reviewed by the Membership Committee and
recommendations are made to the Board of Governors.
To process a new investigator nomination, all of the
following information must be received by the Operations Office
by March, 11, 2005:
• Application for New Investigator Form
• Nomination letter from the Principal Investigator
• Copy of the nominee’s most recent curriculum vitae stating
whether or not the nominee is board certified
• Certification of Education in the Protection of Human Subjects
• New investigator pharmacy information
• Affirmation of Integrity Statement
• Purchase Service Agreement (Affiliate investigators only)
Incomplete nominations will not be processed until a
complete packed is received. For a complete outline of the nomination
process, refer to Southwest Oncology Group Policy Memorandum
No. 7 at the Group’s Web site, http://swog.org. The Application for
New Investigator Form can be downloaded and printed.

Page 16
THE GROUP NEWSLETTER
A report from the committee vice chairman
News from the Nurse Oncologist Committee
By Lisa Hansen, Acting Chair
With the resignation in September of former Committee
Chair Carolyn Schmidt, RN, MSN, nominations for chair and vice
chair are being accepted by Southwest Oncology Group Chairman
Dr. Charles Coltman. Carolyn resigned to take a new position in
pharmaceutical research.
Carolyn served as the Disease and Discipline Committee
co-chair from 1996 to 2003 before her appointment as chair of the
Nurse Oncologist Committee (NOC) in July 2003. Many projects
were initiated during her tenure, and she and Disease and Discipline
Co-chair Deborah Ward were instrumental in developing the Fast
Fact Sheets for protocols and formalizing the nurse liaison protocol
review process.
Nurse Oncologist Committee members have been busy
with several projects designed to improve the clinical trials process
and provide valuable information to Southwest Oncology Group
members. Several of these activities are described elsewhere in this
newsletter. We welcome new nurse oncologists and experienced
members to join us in providing these vital programs to the Group
membership. Feel free to contact any of the Nurse Oncologist
Executive Committee members listed in the box below for more
information.
Disease and Discipline
The Disease and Discipline Committee has three
functions:
• The first is to ensure there are nurse liaisons on each
disease committee to review protocols in development as well as
to develop the Fast Fact Sheets that have become so useful.
Currently, all liaison positions are full with the exception of
leukemia. I will be contacting nurses who have expressed an
interest in serving in this capacity. We generally conduct business
by email, but liaisons are requested to attend at least one meeting
a year.
• The second committee function is the Clinical Trials
Nurse Mentorship Program, developed by Rose Ermete. Rose
reported on the program at the ONS congress in the spring and is
looking for a member interested in participating.
• The third committee function is providing education for
nurses who act as quality-of-life coordinators on the various
protocols. We are going to maintain a list of these nurses to use as
resources, and have nurses ready to assume the role of QOL
coordinator. More training will be offered at the Spring 2005
Group Meeting. Contact Deb Ward at dward@providencehospital.org
if you have questions.
Membership Committee
Nine new committee members were approved at the Nurse
Oncologist Committee Executive Committee Meeting. They are
Rose-Mary Ashworth, Houston, Texas; Pamela Bishop,
Spartanburg, SC; Wanda Burdette, Spartanburg, SC; Carol Drum,
Spartanburg, SC; Julie Ferguson, Albuquerque, NM; Pamela
Richardson, Wichita, KS; Sandra Sandoval, Wichita, KS; Nancy
Sprouse, Spartanburg, SC; and Crystal Watson, Wichita, KS. The
committee membership now stands at 115.
Education Subcommittee
Dorothy Coleman reported that the Education
Subcommittee is developing an audit manual to be placed on the
Southwest Oncology Group Web site for use by auditors and
institutions.
A first draft was submitted at the fall Group meeting. The
final draft will be submitted in January, when it will be distributed
to the QA Task Force, Statistical Center and Operations Office for
Continued on next page.
Administrative Contacts
Position/Name Telephone e-mail address
Chair: Pending approval
Vice-chair: Lisa Hansen (503) 4113-6285 lhansen@lhs.org
Secretary: Linda Davis (313) 745-2188 ldavis6@dmc.org
Disease & Discipline: Deborah Ward (248) 849-8115 dward@providence-hospital.org
Ruth Chaplen (313) 745-2798 chaplenr@karmanos.org
Education: Dorothy Coleman (808) 586-2979 dorothy@crch.hawaii.edu
Pamela Williams (864) 560-6812 pwilliam@.srhs.com
Juanita Garrison (859) 323-6539 jgarr2@email.uky.edu
Program: Rose Ermete (313) 916-7231 rermete1@hfhs.org
Karen Mack (501) 296-1502, ext. 1231 mackkaren1@uams.edu
Research: Maggie Ramsey (806) 354-5875, ext. 139 mramsey@harringtoncc.org
Shirley Raltz (206) 215-3241 Shirley.raltz@swedish.org
Membership: Patra Grevstad (206) 386-2442 patra.grevstad@swedish.org
CCOP: Marge Good (316) 268-5784 marge_good@via-christi.org
Cancer Control: Lisa Hansen (503) 413-6285 lhansen@lhs.org
DECEMBER 2004

THE GROUP NEWSLETTER
Nurse Onocologist Committee (Continued)
comments and revisions. The manual should be finalized for the
April Group meeting in Denver. In April, QA Manager Elaine
Armstrong will be holding an audit workshop for auditors. She has
also agreed to do a presentation at the Education Subcommittee
meeting in Denver with CEUs.
In other committee business, Marge Good mentioned that
the Cancer Trials Support Unit has agreed to have the institutions
call the research bases directly instead of calling CTSU. Many
problems have improved, but regulatory issues are ongoing.
Program Subcommittee
The Program Subcommittee met jointly with the
Education Subcommittee to discuss planning for future programs.
They agreed to continue presenting a disease-focused program at
fall Group meetings and more general topics at spring meetings.
They also agreed to explore the idea of having a Thursday evening
event at future Group meetings.
Research Subcommittee
The Research Subcommittee has decided to start an e-
mail network to discuss research-related topics. If you are interested
in being a part of this forum, e-mail your name, address and
institution to Shirley.raltz@swedish.org.
Page 17
Most current and upcoming cancer control trials provide
a minimum 1.0 cancer control credit for CCOPs and “per-case”
financial reimbursement for non-CCOP institutions.
Committee on Special Populations
This multidisciplinary committee continues to move
forward with multiple proposals that address survivorship research,
comprehensive elderly research strategies, and special populations
accrual and outcome. A trial evaluating late effects of cisplatin in
cancer survivors is in protocol development.
Many additional projects are under development in
collaboration with various disease committees or Cancer Control
Research subcommittees. Lay advocates play a vital role by
contributing ideas to protocol development and increasing
awareness of Southwest Oncology Group trials throughout their
networks.
Calling all nurse researchers!
The Nurse Oncologist Committee is seeking people interested
in presenting posters at the Group meeting in Denver, April 6-
10. Abstracts for poster presentations should be submitted by
January 31, 2005. Please contact Shirley.raltz@swedish.org, (206)
215-3241, for more information.
Community Clinical Oncology Program
Discussion was held regarding issues related to the Cancer
Trials Support Unit (CTSU). Many previous issues with the CTSU
have been resolved and improved upon as a result of the CCOP/
CTSU Advisory Panel discussions, in which Marge Good and Pam
Williams have participated. Marge asked the group to provide
ideas for discussion at future meetings. This is the only opportunity
within the cooperative groups meetings that CCOP nurses can
meet and discuss “grass roots” issues.
Cancer Control Liaison
Several new cancer control studies are available to
Southwest Oncology Group institutions including:
• An exercise intervention in lung cancer patients (S0229)
• A limited institution trial assessing barriers to accrual of
older patients to cancer clinical trials (S0316)
• S0205, a trial focusing on pain and quality-of-life
outcomes in patients with pancreatic cancer receiving treatment
with gemcitabine +/- cetuximab
P
C
P
T
• The oral mucositis trial, S9908, has been re-activated
and new procedures are in place for drug reconstitution.
P
H
O
T
O
S
The next six months will bring trials in molecular
epidemiology of lung cancer, cervical cancer chemoprevention, a
limited institution breast chemoprevention trial and a melanoma
chemoprevention trial. CASE, the next colon cancer prevention
trial, is moving forward in development.
Nurse quality-of-life coordinators are assigned to five
trials with QOL or other health outcomes measures. A new RTOGcoordinated
trial assessing multimodality treatment approaches in
locally advanced non-small-cell lung cancer will open soon. This
trial includes a quality-of-life assessment.
DECEMBER 2004
CCRP exam to be offered
at the spring Group meeting
The Society of Clinical Research Associates (SoCRA)
certification examination will be offered at the Spring 2005
Southwest Oncology Group Meeting in Denver, provided at
least 10 applicants are registered for the exam.
The purpose of the certification program is to create an
internationally accepted standard of knowledge, education
and experience by which clinical research associates will be
recognized as professionals in medical research. Individuals
who earn a passing score on the examination may use the title
“Certified Clinical Research Professional” or the initials
“CCRP” after their name.
Applicants must be members of SoCRA in good standing or
apply for membership and the certification examination
simultaneously. Applicants also must have been employed for
two of the past five years as a clinical research associate.
The certification examination consists of five major
content areas:
1. Conduct of clinical trials
2. Institutional review boards and regulations
3. Ethical issues
4. Ability to follow directions
5. Abstracting information from medical records.
Applications for the certification examination and
membership in SoCRA may be obtained by calling (800)
SOCRA92 or (215) 345-7749, or by accessing http://
www.socra.org.
The Southwest Oncology Group contact persons are
Jacqueline Hilger, (562) 933-7861and Debbie Christie, (601)
984-1099.

Page 18
THE GROUP NEWSLETTER
Partnerships For Life brochure available to institutions soon
The Partnerships for Life Program brochure
developed by the Clinical Research Associates and
Nurse Oncologist committees will be available
shortly for distribution. When they are available,
an announcement will be posted on the CRA
Workbench and an e-mail will be sent on the CRA
list serve.
The Partnerships for Life Program
brochure is a tool to assist CRAs and Nurse
Oncologists in reinforcing the patient’s role
as a key member of the research team, as well
as a way to foster relationships with patients
enrolled in Southwest Oncology Group
studies from the time they are screened
through the years of follow-up.
After presentations at the CRA
Plenary Session, Nurse Oncologist
Committee Meeting and Open Forum during
the Fall 2004 Group Meeting, attendees came up with
many different ways of using this brochure, including:
• Sending it to patients with an introductory cover
letter when a new staff member responsible for follow-up joins
an institution.
• Including it with a cover letter to patients who are
delinquent in follow-up or hard to reach.
• Mailing it to patients once a year to
remind them of their commitment to the
study.
• Giving it to patients at enrollment
so that they see from the start that they are part
of a team effort.
• Sending it to patients along with study
results after publication. (Patients are very
interested in the results of “their” study!)
• Providing it to member institutions that take
over follow-up from an affiliate.
There must be many other ways to use this brochure
after it becomes available and the CRA Committee
would like to know how you’ve used it and if you feel
it is beneficial to you. We encourage you to order the
brochures and give the committee feedback at the next
Group meeting.
These brochures are free to institutions through the
generosity of The Hope Foundation.
Group changing the way serious adverse events are reported
Two recent changes affect how serious adverse
events (SAE) are reported within the Southwest Oncology
Group.
New SAE format
In September, the Southwest Oncology Group adopted
the standardized SAE guidelines format that was designed by an
intergroup committee. It is important to note that the investigational
and commercial drug SAE reporting guidelines themselves
have not changed, only the way the guidelines are laid out
in Section 16 of Group protocols. To better understand the new
format and guidelines for reporting serious adverse events,
consult the new SAE appendix that has been added to the
protocols.
AdEERS Version 5.0
The second change in reporting serious adverse events
occurred last summer when the National Cancer Institute (NCI)
released Version 5.0 of Adverse Event Expedited Reporting
System (AdEERS). This new version expands the reporting
capability of the online system beyond NCI-held investigational
drugs, to which it was originally limited, to include all kinds of
SAE reporting. This includes protocols using investigational
drugs, commercial drugs, surgery or radiotherapy. Therefore,
all new SWOG therapeutic protocols and most active treatment
protocols still open to accrual will now use AdEERS to report
DECEMBER 2004
SAEs. Revisions to the open protocols affected by this change
are being gradually issued to reflect both this switch to all-
AdEERS reporting and the new SAE guidelines format mentioned
above.
Here are a few helpful hints about using the new
AdEERS reporting system:
* Southwest Oncology Group still requires that you
contact the Operations Office at 210-677-8808 within 24 hours
of learning of a potentially reportable adverse event.
* AdEERS Version 5.0 gives you more flexibility so you
can delete sections of a report that are not applicable. Look
carefully at the “Sections of Report” page in AdEERS. You can
click “no” to any sections that are not relevant to the adverse
event you are reporting.
* On an AdEERS report, it is not necessary to show
Concomitant Medications that are not at least “possibly” related
to the adverse event being reported.
While the lead time for submitting supporting documentation
following an initial SAE report has been decreased
from 10 working days to seven, the amount of documentation
has also been decreased. Usually, only three items will now be
needed to substantiate an SAE report: a copy of the AdEERS
report, a copy of IRB notification and copies of the relevant
clinical records or other source documents that provide details
about the adverse event you are reporting.

THE GROUP NEWSLETTER
VIDEOTAPE ORDER FORM
CLINICAL RESEARCH ASSOCIATES COMMITTEE
DECEMBER 2004
Page 19
__ Everything You Need to Know About Radiotherapy...But, Were Afraid to Ask (4/98)
__ Side Effects and Toxicities of Radiation Therapy (4/98)
__ GU Diseases: Renal Cancer Overview (4/98)
__ GU Diseases: Locally Advanced Bladder Cancer Overview (4/98)
__ GU Diseases: Advanced Bladder Cancer Overview (4/98)
__ Adrenal, Prostate & Testicular Cancer: Surgical Overview; Pathological Overview (10/98)
__ Adrenal, Prostate & Testicular Cancer: Radiation Therapy; Medical Oncology; Introducing CAPRI
(Cancer of the Prostate Risk Index); Panel Discussion (10/98)
__ Head & Neck Cancer: Preneoplasia, Chemoprevention, Organ Preservation (10/99)
__ Head & Neck Cancer: Resectable Carcinoma, Adjuvant Therapy, Unresectable Disease (10/99)
__ Immunologic Therapy: Vaccine Therapy (4/00)
__ Immunologic Therapy: Antibody Based Therapies (4/00)
__ Immunologic Therapy: Intermediate Endpoints in Cancer Immunotherapy (4/00)
__ IRB Basics & Beyond (4/00)
__ Brain Tumors: Surgical management; Pathology (10/00)
__ Brain Tumors: Radiotherapy; Chemotherapy (10/00)
__ Federal Guidelines Governing Research and IRBs: Trends in Research Ethics; Historical Perspectives to Current
Climate of Research; OHRP Changes and New Directions (4/01)
__ Quality Improvement; Achieving Compliance; Hot Spots & Various Sundries (4/01)
__ Handling Misconduct in Clinical Research (4/01)
__ Common SWOG Audit Deficiencies; The IRB Decision Process (4/01)
__ Breast Carcinoma: Surgical Intervention & New Techniques, Role of Immunohistochemistry in Cancer Diagnosis (4/02)
__ Breast Carcinoma: Biomarker Studies; What’s New in Adjuvant Therapy for Breast Cancer (4/02)
__ CRA Plenary Session: Surviving Breast Cancer; Dealing with a Diagnosis of Breast Cancer (4/02)
__ CRA Plenary Session: Surviving Prostate Cancer; Reconstructive Surgery After a Mastectomy (4/02)
__ HIPAA: The HIPAA Privacy Rule and Research (10/02)
__ HIPAA: HIPAA Compliance in the Research Setting (10/02)
__ Leukemia: CRAs Perspective on Leukemia Trials; AML in Younger Patients (10/03)
__ Leukemia: Pathology of Leukemia; AML in Older Patients (10/03)
__ Radiation Therapy and New Imaging Techniques: RT101 and RT/QA; QARC; Cranial/Extracranial Radiosurgery
Techniques -- First Half (4/04)
__ Radiation Therapy and New Imaging Techniques: Cranial/Extracranial Radiosurgery Techniques -- Second Half;
Imaging Techniques -- PET, Cone Beam CT, Spect, MRS; Panel Discussion (4/04)
__ IATA Training for Shipping Dangerous Goods (10/04)
MAIL TAPES TO:
NAME:
ADDRESS:
DEPT:
The Southwest Oncology Group Quality Assurance
ZIP Department CODE: is recruiting additional
CITY: STATE:
TELEPHONE: ( ) AFFILIATION/INSTITUTION:
Nurse Auditors to assist in Quality Assurance
_____ I assume responsibility for the prompt and safe treatment return of audits. all tapes All requested. travel expenses There are will covered
is a by maximum the Southwest one (1) month Oncology loan Group period. and
be a
$10 replacement fee for damaged or lost tapes. There
auditors are eligible to receive ICS points on
SIGNATURE:
their grant continuation for every audit in which
NOTE: If several tapes are ordered, it may take up to several months to complete the order due to demand.
they participate. Turn to page 18 and complete
the Nurse Auditor Application.
MAIL ORDER FORM TO: Jacqueline Hilger, B.S., M.S., CCRP, Research Director, Breastlink Medical Group,
701 East 28th Street, Suite 412, Long Beach CA 90806.

Page 20
Are you an experienced CRA but still need some help
You may already know about the CRA Committee
Mentor Program to help CRAs new to Southwest Oncology
Group contact experienced CRAs for help with protocol
questions, forms completion or anything else to do with a
SWOG study.
But did you know that this program is also available to
3, and 11/
Phyllis Stein Beal, BS, CCRP
Grand Rapids Clinical Oncology Program
75 Sheldon SE, Suite 101
Grand Rapids, MI 49503
616- 391-1230
phyllis.stein@grcop.org
Specialty: IRB, Brain, CCOP Issues
Susan Berry, RN, BSN
Urology Research Coordinator
Henry Ford Hospital K-933E
2799 West Grand Blvd.
Detroit, MI 48202
313-916-2438
sberry1@hfhs.org
Specialty: GU
Debra W. Christie, MBA
University of Mississippi Medical Center
Cancer Research & Registry
2500 N. State Street
Jackson, MS 39216-4504
601-984-1095
dchristie@crr.umsmed.edu
Specialty: GU, Institutional Administrative
Issues
Anita M. Crosena, CCRA
Clinical Trials Office
Community Cancer Care Specialists
1030 Harrington, Suite 301
Mount Clemens, MI 48043
586-493-3426
acrosena@prodigy.net
Specialty: General
Meredith Dawson, RN, MA
St. Charles Medical Center
2500 NE Neff Road
Bend, OR 97701
541-317-4359
mdawson@scmc.org
Specialty: IRB
Beth Davis, CRA
Manager, Clinical Research
Alta Bates Comprehensive Cancer Center
2001 Dwight Way
Berkeley, CA 94704
510-204-3428
bdavis@salick.com
Specialty: GI, Transplant
CRA Mentor Roster
DECEMBER 2004
THE GROUP NEWSLETTER
help experienced CRAs Perhaps you have changed jobs at
your institution and need help with head CRA issues or just
need a little guidance on something new.
Clip and save the mentor list below so that when the
need arises you can easily find a mentor with similar interests.
Gina Gregovich, BS, CCRP
Huntsman Cancer Institute
University of Utah
2000 Circle of Hope, Room 2160
Salt Lake City, UT 84112
801-585-5164
gina.gregovich@hci.utah.edu
Specialty: Lymphoma
Betsy Higgins, CCRA
Project Coordinator, SABOR
University of Texas Health Science Center
7703 Floyd Curl Dr.
San Antonio, TX 78229-3900
210-567-0214
higginsb@uthscsa.edu
Specialty: GU
Jennifer Katz, CCRP
Huntsman Cancer Institute
2000 Circle of Hope, Room 2125
Salt Lake City, UT 84112
801-585-0571
Jennifer.Katz@hci.utah.edu
Specialty: General
Diana Lowry, BA
SWOG Statistical Center
Data Operations Technical Manager
1730 Minor Avenue, Suite 1900
Seattle, WA 98101-1468
206-652-2267
dianal@crab.org
Specialty: Myeloma, Breast, Cancer Control
Carolyn Massarello, CCRA
Department of the Army
Brooke Army Medical Center
ATTN: MCHE-MDH (SWOG)
Bldg. 3600, 3851 Roger Brooke Dr.
Fort Sam Houston, TX 78234-6200
carolyn.massarello@amedd.army.mil
Specialty: General
Mary McGreevy, CCRA
Bay Area Tumor Institute
400 30 th Street, Suite 301
Oakland, CA 94609
510-465-8502
mmcgreevy@bati.org
Specialty: Melanoma
Continued on page 22.

THE GROUP NEWSLETTER
Clip & Save
ADDRESS & PHONE NUMBERS
Southwest Oncology Group Operations Office
14980 Omicron Drive, San Antonio, TX 78245-3217
Phone: 210-677-8808 FAX: 210-677-0006
Home page: http://swog.org
Cancer Research And Biostatistics (CRAB)
Phone: 206-652-9711 FAX: 206-652-4612
••••••••••
Therapeutic Data Operations Center at CRAB
c/o Cancer Research and Biostatistics
1730 Minor Avenue, Suite 1900
Seattle, WA 98101-1468
Fax Data Submission: 800-892-4007
or 206-342-1680
Phone: 206-652-2267 Correspondence Fax: 206-652-4612
Delivery (FedEX, UPS, etc.):
SWOG Data Operations Center
c/o Cancer Research & Biostatistics
1730 Minor Avenue, Suite 1900
Seattle, WA 98101-1468
••••••••••
SELENIUM and VITAMIN E
CANCER PREVENTION TRIAL (SELECT)
1730 Minor Avenue, Suite 1900
Seattle, WA 98101-1468
Deliveries: Same address shown above.
Phone: 206-652-1338 Correspondence Fax: 206-652-1339
Fax Data Submission: 888-652-2940 or 206-839-1726
Page 21
Statistical Center Staff News
New Staff
Brian Zeller transferred from SELECT to join the
Therapeutic Data Operations Staff as a data coordinator. Brian
is a data coordinator for the GU and Melanoma committees. In
addition, therapeutics welcomes another data coordinator,
Cynthia Hill. Cynthia has been assigned to the Head and Neck
and Breast committees.
SELECT News
SELECT welcomes new Data Coordinator Sarah Effert,
who joined the staff in July. Sarah has experience as a CRA at
Swedish Medical Center in Seattle as well as a therapeutic data
coordinator at the Statistical Center.
Now that SELECT accrual has ended, SELECT
Recruitment and Adherence is now known as Retention and
Adherence. Karen Anderson’s position is now Retention and
Adherence Manager, Russell Campbell is Retention and
Adherence Coordinator Lead and Sharon Moon is Retention
and Adherence Coordinator.
Staff changes
Rodney Sutter was promoted to data operations manager
and Scott Kurruk has been promoted to data operations supervisor.
Carolyn Jiang, M.S., is leaving the Statistical Center to
take a position in sunny Hawaii! Caroline started her career at the
Stat Center as a graduate student research assistant and was later
promoted to statistical research associate working on the
Gynecology, Breast and Cancer Control Research disease
committees.
Births
Marlyn Joseph Nicholas was born July 14 to Danika Lew
and Jim Nicholas. Audrey Mae Gundacker was born Aug. 23 to
Holly Gundacker.
Operations Office Staff News
Rosanne Fohn joined the Operations Office in September
as Communications Coordinator. Rosanne has more than 20
years’ experience in communications as a newspaper journalist
and magazine writer, as well as six years experience in corporate
communications in the financial services industry.
PROSTATE CANCER PREVENTION TRIAL (PCPT)
Southwest Oncology Group Statistical Center
Fred Hutchinson Cancer Research Center
1100 Fairview Avenue North, M3-C102
P. O. Box 19024
Seattle, WA 98109-1024
Phone: 206-667-6868 FAX: 206-667-6869
DECEMBER 2004

Page 22
THE GROUP NEWSLETTER
Dr. Vernon Sondak wins
Hope Foundation Porsche
Grinning from ear to ear, Dr. Vernon K. Sondak accepted the
keys to a brand new Porsche during the fall Group meeting cocktail party,
courtesy of The Hope Foundation’s Platinum Association prize drawing.
Sondak is chairman of the Southwest Oncology Group Melanoma and
Surgery committees.
Dr. Laura F. Hutchins of the University of Arkansas for Medical
Science won a pair of Southwest Airlines tickets and accommodations for
two at the Huntington Beach Hyatt Resort. Dr. James K. Weick of
Hematology Oncology Associates in Lake Worth, Florida, also won airline
tickets and accommodations for two at the Hyatt Hotel in Las Vegas.
The Southwest Oncology Group
gratefully acknowledges
support from the following sponsors
for the Fall 2004 Group Meeting
PATRON
Abbott Pharmaceuticals
Aventis Oncology
Genentech BioOncology
GlaxoSmithKline
Novartis Oncology
CENTURION
Millennium Pharmaceuticals, Inc.
Ortho Biotech
PACESETTER
Amgen
Biogen IDEC
EMD Pharmaceuticals
OSI Oncology
Roche Laboratories, Inc.
Sanofi-Synthelabo, Inc.
SUPPORTER
AstraZeneca
Berlex Oncology
Cell Therapeutics, Inc.
Chiron Corporation
DDOTS, Inc.
Eli Lilly & Company
MedImmune
Pfizer, Inc.
Pharmion Corporation
SuperGen
DECEMBER 2004
Dr. Vernon Sondak sits behind the wheel of the new Porsche he won in
The Hope Foundation’s Platinum Association prize drawing at the
Southwest Oncology Group Fall Group Meeting in Kansas City.
Mentoring list (Continued from page 20)
Virginia McMahon, CCRA
Cancer Research Center of Hawaii
1236 Lauhala Street, Room 402
Honolulu, HI 96813
808-586-2979
virginia@crch.hawaii.edu
Specialty: Brain
Eileen Sembrowich, BS, BA, CCRA
Stone Oak Physician’s Plaza II
544 Oak Center Dr., Suite 100
San Antonio, TX 78248
210-404-0606
esembrow@saci.org
Specialty: General
Lisa Stoppenhagen, CCRP
St. Luke’s RMC/MSTI
100 E. Idaho Street
Boise, ID 83712
208-381-3155
stoppenl@slrmc.org
Specialty: Transplant
Merle Thiele Witter, CCRP
3713 75 th Avenue Court, NW
Gig Harbor, WA 98335
253-265-8926
merle.witter@hci.utah.edu
Specialty: IRB
Pam Williams, RN, MSN, CCRA
Director, Clinical Research
Gibbs Regional Cancer Center
Spartanburg Regional Medical Center
101 East Wood Street
Spartanburg, SC 29303
864-560-6812
pwilliam@srhs.com
Specialty: Breast, IRB, CCOP issues

THE GROUP NEWSLETTER
Page 23
A gift for the holidays:
Star Palate celebrity cookbook
When Dr. Saul Rivkin’s wife died several years ago
of ovarian cancer, he and his five daughters established the
Marsha Rivkin Center for Ovarian Cancer Research in her
memory at Swedish Health Medical Center in Seattle.
Dr. Rivkin, a member of the Southwest Oncology
Group for many years, has been principal investigator of Puget
Sound Oncology Consortium in Seattle since 1973 and is chair
of the Clinical Practices Committee. He is a member of the
Breast, Lymphoma and Sarcoma committees.
Meanwhile, tennis star Andre Agassi’s sister Tammi
was diagnosed with breast cancer at age 30. Now with her
cancer in remission, Agassi works as executive director of the
Marsha Rivkin Center. Having undergone treatments for breast
cancer herself and understanding the need for cancer research
funding, Agassi created the STAR Palate Celebrity Cookbook
for a Cure, featuring recipies 79 from such stars as Robin
Williams, Katie Couric, Jay Leno, Quincy Jones, Celine Deon,
Tim McGraw, Andre Agassi and many more.
All proceeds from the cookbook sale benefit the
Marsha Rivkin Center for Ovarian Cancer Research and The
Breast Cancer Research Foundation. Cookbooks can be purchased
though major national bookstores.
CRA Plenary Session Subcommittee
Communications: Beth Davis bdavis@salick.com
Continuing Education: Anita Crosena acrosena@prodigy.net
Head CRA: Phyllis Stein Beal Phyllis.Stein@grcop.org
Open Forum: Lynn Campbell lynnc@orhs.org
Posters: Jacqueline Hilger hilger@breastlink.com
Program: Virginia McMahon Virginia@crch.hawaii.edu
Survivor Program: Jacqueline Hilger hilger@breastlink.com
2004-2005 Holiday Schedule
Operations Office—
Christmas Eve, December 24, 2004
New Years Eve, December 31, 2004
Battle of Flowers, April 22, 2005
—Statistical Center Staff
at Fred Hutchinson Cancer Research Center—
Christmas Eve, December 24, 2004
Martin Luther King Day, January 17, 2005
Presidents’ Day, February 21, 2005
—All CRAB Offices—
Christmas Eve, December 24, 2004
New Year’s Eve, December 31, 2004
Martin Luther King Day, January 17, 2005
Presidents’ Day, February 21, 2005
DECEMBER 2004
CRAs seeking input for plenary
Sarcoma will be the topic of the CRA workshop to
be held at the Spring 2005 Group Meeting April 6-10 in
Denver. The CRA Plenary Session will cover funding issues
and include a panel discussion on CRA workload.
If you have suggestions for future meeting topics,
please contact one of the Subcommittee Chairs listed above.
CRA Committee needs volunteers
The CRA Committee has openings for Disease
Committee representatives for the Bone Marrow Stem Cell
Committee and the Intergroup Coalition Against Sarcomas.
If you are interested and work with studies in these
disciplines, please contact Beth Davis, CRA Communications
Committee Chair, at bdavis@salick.com.