GYNECOLOGIC COMMITTEE - SWOG

GYNECOLOGIC COMMITTEE 

Maurie Markman, M.D., Chair 

David S. Alberts, M.D., Vice-Chair 

Pages: GYN- 1-17

Program Director/Principal Investigator (Last, First, Middle): 

Baker, Laurence H., D.O. 

ABSTRACT 

The SWOG Gynecologic Committee (GC) has been through many changes since the last 

renewal. In 2003, despite the long-standing and highly successful role played by SWOG in 

gynecologic cancers for more than 20 years, the group elected to close its gynecologic cancer 

clinical research efforts just prior to the last group site visit. The reason for the closure was 

principally due to inadequate accruals onto SWOG-initiated phase III clinical trials. However, 

when Baker took over as the Chair of SWOG, one of his goals was to reactivate the 

Gynecological Committee. This effort was strongly supported by the National Cancer Institute 

and has been endorsed by the Gynecologic Oncology Group (GOG). Thus, in 2007, the GC 

was reactivated with Maurie Markman as the Chair and David Alberts as the Vice -Chair. The 

focus of the GC is the conduct of phase II trials (both single arm and randomized) with the 

potential for phase I/II trials, and possibly in the future, phase III studies. The GC’s efforts will 

include trials in several clinical settings involving women with cancers of the ovary, endometrium 

and cervix. The Marsha Rivkin Foundation for Ovarian Cancer Research has provided an 

extremely generous $250,000 grant to support this new initiative within SWOG. 

Since it is clear that many academically-oriented medical oncologists with a strong research 

interest in the field of gynecologic cancers are not based at SWOG institutions, SWOG has 

extended special membership privileges to such highly qualified individuals in order to broaden 

and strengthen the impact of GC clinical trials. This “Special Membership” permits these 

physicians to: 1) fully participate in protocol design, coordination, and publication of SWOG GC 

studies; 2) register and treat patients on appropriate SWOG GC protocols; 3) receive drugs 

allocated to the Group to conduct GC studies (Licensed Physicians only); and 4) be elected or 

appointed to any position and/or any Committee of the Group. 

Since reactivation of the GC in early 2007, the GC has had two planning meetings and the first 

official committee meeting at the Spring 2008 SWOG conference in Atlanta. All of the meetings 

have been well attended. The GC has also had a number of committee-wide conference calls 

to discuss protocol concepts submitted for review, and the development of a robust clinical 

research agenda. 

At this time (August 2008), we have three concepts approved the SWOG Executive Committee, 

and several additional concepts approved by the GC membership pending approval by the 

SWOG Executive Committee. 

It is our anticipation that we will be able to initiate clinical trial accrual in early 2009. Of note, the 

SWOG GC will also participate in NCI-sponsored randomized phase III trials (e.g. GOG, RTOG) 

and studies being conducted through the Gynecological Cancer Intergroup, of which SWOG is a 

full member. SWOG also participates in the Gynecologic Cancer Steering Committee, which is 

the review body for NCI-supported gynecologic clinical trials. This addition of SWOG to this 

national and international effort will hopefully permit the more timely completion of definitive 

randomized phase III clinical trials. 

GYNECOLOGIC COMMITTEE GYN- 1



COMMITTEE MEMBERSHIP 

COMMITTEE LEADERSHIP 

Chair: 

Vice-Chair: 

Executive Officer: 

Statistician: 

SCIENTIFIC LEADERSHIP 

Translational Medicine 

Translational science: 

Early Therapeutics: 

Radiation Oncologist: 

Surgical Oncologist: 

Medical Oncologist: 

Pathologist: 

Committee Specific 

DESIGNATES 

Clinical Research Associate: 

Control/Prevention Liaison: 

Data Coordinator: 

Nurse: 

Pathologist: 

Patient Advocate: 

Pharmacist: 

Protocol Coordinator: 

Statistician: 

Maurie Markman, M.D. 

David S. Alberts, M.D. 

Anne Schott, M.D. 

Garnet Anderson, PhD. 

Stephen Howell, M.D. 

Joy Anderson, M.D. 

Sharon P. Wilczynski, M.D., PhD. 

Jean Barce 

Sharon P. Wilczynski, M.D., PhD. 

Laurel Pracht 

Gretchen E. Goetz 

James Moon, M.S. 

Currently, membership on the newly formed SWOG GC includes 17 individuals from SWOGbased 

institutions and 25 “Special Members” from non-SWOG institutions. 

Full Members include: 

Arizona Cancer Center 

David Alberts 

Setsuko Chambers 

University of New Mexico 

Claire Vershreagen 

Carolyn Muller 

University of California at Irvine 

Brad Monk 

Bob Burger 

University of California at Davis 

Sidney Scudder 

University of Texas at Amarillo 

Rusty Robinson 

University of Southern California 

Agustin Garcia 

Baylor College of Medicine 

Matt Anderson 

City of Hope 




Sharon Wilczynski 

Loyola University 

Ronald Potkul 

Laura Horvath 

University of Michigan 

Kevin Reynolds 

Ronald Buckanovich 

New York University School of Medicine 

Amy Tiersten 

Private Practice 

Patricia Braly 

Special Members include: 

Dana Farber Cancer Center 

Akila Viswanathan 

Susana Campos 

Massachusetts General Hospital 

Annekathryn Goodman 

Marcela del Carmen 

Linda Duska 

Richard Penson 

Carolyn Krasner 

Beth Israel Deaconess Medical Center 

Stephen Cannistra 

John Hopkins Kimmel Cancer Center 

Teresa Diaz-Montes 

Deborah Armstrong 

Robert Giuntoli 

University of Chicago Medical Center 

Gini Fleming 

Diane Yamada 

Sarah Temkin 

Memorial Sloan Kettering Cancer Center 

Katherine Bell-McGuinn 

Anne Chiang 

Martee Hensley 

William Tew 

Fox Chase Cancer Center 

Russell Schilder 

Lainie Martin 

Mark Morgan 

Harry and Jeannette Weinberg Cancer Institute 

William McGuire 

University of California San Diego 

Stephen Howell 

Women & Infants Hospital of Rhode Island 

Don Dizon 

Montefiore Medical Center 

Harriett Smith 




The GC communicates through conference calls and email in addition to the Fall and Spring 

SWOG meetings. Since reactivation of the GC in early 2007, the GC has had two planning 

meetings and the first official committee meeting at the Spring 2008 SWOG conference in 

Atlanta. All of the meetings have been well attended. The GC has also had a number of 

committee-wide conference calls to discuss protocol concepts submitted for review, and the 

development of a robust clinical research agenda. 


Program Director/Principal Investigator (Last, First, Middle): Baker, Laurence H., D.O. 

PROTOCOLS ACTIVE DURING REPORT PERIOD 

Admin 

Phase/Coordinating Group 

StudyID 

Accrua 

l 

2004 

Accrua 

l 

2005 

Accrua 

l 

2006 

Accrua 

l 

2007 

Accrua 

l 

2008 

Total 

2003 

- 

2008 

Total in 

Followup 

Accr 

Prev 

Period 

1998- 

2003 

Total 

Accrua 

l 

for 

Study 

GYN Phase II S0009 11 13 4 0 0 28 13 34 62 

GYN Phase II S0211 17 3 0 0 0 20 0 14 34 

GYN Phase II S9912 13 7 0 0 0 20 30 48 68 

GYN 

GYN 

Phase III,Intergroup (SWOG coordinated) S0200 35 0 0 0 0 35 12 26 61 

Phase III,Intergroup (non-SWOG 

coordinated) G0182 55 0 0 0 0 55 183 144 199 

Closed 

02/01/200 

6 

01/01/200 

6 

08/15/200 

5 

12/15/200 

4 

09/01/200 

4 

*Registrations are through 012/31/2008 

**Other Includes non-tx Intervention (symptom control)","Pilot","Quality of Life","Treatment (Prevention)" and "Treatment 

(Symptom)". 




RELEVANT PAST, CURRENT AND FUTURE STUDIES 

Recently Completed 

S0009: Phase II Evaluation of Neoadjuvant Chemotherapy, Interval Debulking Followed by 

Intraperitoneal Chemotherapy in Women With Stage III and IV Epithelial Ovarian Cancer, 

Fallopian Tube Cancer or Primary Peritoneal Cancer (Activated: 3/15/01; closed 2/01/06) 

Schema 

STAGE III OR PLEURAL EFFUSION ONLY STAGE IV EPITHELIAL OVARIAN CARCINOMA, 

PRIMARY PERITONEAL OR FALLOPIAN TUBE CARCINOMA (LARGE PELVIC MASS AND/OR 

BULKY ABDOMINAL DISEASE AND/OR MALIGNANT PLEURAL EFFUSION) DEEMED UNLIKELY 

TO BE OPTIMALLY CYTOREDUCED BY EVALUATING SURGEON 

INITIAL REGISTRATION 

NEOADJUVANT IV PACLITAXEL 

AND CARBOPLATIN 

Q 3 WEEKS X 3 COURSES 

≥ 50% decrease in CA-125 

from baseline 

< 50% decrease in CA-125 

from baseline 

EXPLORATORY LAPAROTOMY/INTERVAL CYTOREDUCTION 

with aggressive attempt to debulk to < 1 cm residual 

OFF PROTOCOL 

TREATMENT 

SUBOPTIMALLY DEBULKED 

OFF PROTOCOL TREATMENT 

OPTIMALLY DEBULKED 

SECOND REGISTRATION 

Mandatory Submission of 

Paraffin Embedded and 

Fresh Tissue 

IV PACLITAXEL 

IP CARBOPLATIN 

IP PACLITAXEL 

X 6 COURSES Q 4 WEEKS 




Rationale 

Despite the high objective response rate to platinum-based chemotherapy, the majority of 

patients with advanced disease ultimately progress and die of complications of the 

malignancy. In this trial we have attempted to take advantage of the intraperitoneal route of 

anti-neoplastic drug delivery by administering regional treatment to patients with bulky Stage 

III and Stage IV disease who have achieved an initial response to primary systemic 

chemotherapy and have small volume residual disease after an interval surgical cytoreductive 

surgery. 

Objectives 

• To evaluate the overall survival and progression-free survival in Stage III or IV 

epithelial ovarian, fallopian tube or primary peritoneal carcinoma patients with bulky 

disease and/or malignant pleural effusions treated with neoadjuvant intravenous 

paclitaxel and carboplatin, cytoreductive surgery and intravenous/intraperitoneal 

paclitaxel and intraperitoneal carboplatin. 

• To estimate the percent of patients successfully cytoreduced to optimal disease (< 1 

cm residual) following neoadjuvant chemotherapy. 

• To evaluate the toxicities associated with this therapy. 

• To explore the relationship between tumor p53 expression, cellular proliferation rate as 

measured by PCNA and apoptotic rate, and human tumor cloning assay results at time 

of debulking surgery with progression-free survival and overall survival in patients 

undergoing cytoreductive surgery. 

Statistical Endpoints 

This study was designed as a pilot Phase II trial to determine the potential of this approach to 

favorably impact survival in advanced ovarian cancer. 

Results 

Sixty-two patients were registered. Four were ineligible. Fifty-six were evaluated for 

neoadjuvant chemotherapy toxicities. One patient died of pneumonia. Five patients had 

grade 4 toxicity, including neutropenia (3), anemia, leucopenia, anorexia, fatigue, muscle 

weakness, respiratory infection, and cardiac ischemia. Thirty-six patients had debulking 

surgery. Two had grade 4 hemorrhage. Twenty-six patients received post-cytoreduction 

chemotherapy. Four had grade 4 neutropenia. At a median follow-up of 21 months, median 

PFS was found to be 21 months and median OS 32 months for all 58 patients. PFS and OS 

for the 26 patients who received IV/IP chemotherapy was 29 and 34 months respectively. 

Publication 

The abstract was presented as an oral presentation at ASCO and has been submitted for 

publication. Additionally, the Gynecologic Cancer Intergroup in Canada is currently 

developing a randomized phase III trial which incorporates the strategy and piloted this in a 

phase II study. 




To Be Activated 

S0821: A Phase II Trial of Axitinib for a Biochemical Recurrence (“Rising CA-125”) in Women 

with Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers after First-Line 

Chemotherapy 

Rationale 

Most women with advanced ovarian cancer will be treated initially with cytoreductive surgery followed 

by platinum/taxane-based chemotherapy, and most (approximately75%) will achieve a complete 

response (CR). However, most of those who achieve a CR will eventually relapse and succumb to 

their disease, despite additional treatment with either surgery or chemotherapy. 

Further, most patients will be followed during and after first-line treatment using the tumor marker CA- 

125. Many patients will be found to have a rising CA-125 level (biochemical recurrence) while they 

are asymptomatic, and virtually all of these will go on to develop objective evidence of measurable 

disease recurrence. The interval between recognition of a rising CA-125 and identification of 

(1, 2) 

measurable disease has been estimated at 3-6 months. 

Axitinib is a selective inhibitor of vascular endothelial growth factor receptor 1,2 and 3. Preclinical 

data suggest that axitinib has antitumor activity that results from its anti-angiogenic effect, which is 

reversible when discontinued. (3) In a Phase I study of 36 patients with advanced solid tumours who 

received axitinib doses ranging from 5 to 30 mg twice daily, the dose-limiting toxicities were 

hypertension and stomatitis. Other toxicities included diarrhea, fatigue, nausea, and vomiting. Axitinib 

was rapidly absorbed, with peak plasma concentration noted 2-6 hours after dosing. (4) Axitinib at a 

dose of 5 mg twice daily was reported to show clinical activity in a Phase II study of metastatic renalcell 

cancer patients, with mild, manageable toxicity. 

Objectives 

To evaluate the recurrence-free interval associated with using axitinib in patients who have achieved 

a complete response to first-line chemotherapy and develop a biochemical recurrence (rising CA-125) 

in the absence of other evidence of disease. 


The goal of the study is to evaluate the recurrence-free survival in patients with ovarian cancer who 

have achieved a complete response to first-line chemotherapy, develop a rising CA-125, (biochemical 

recurrence) and use axitinib. For purposes of this study, we estimate that the median time from 

enrollment to documentation of recurrent disease by RECIST is 3 months. It is assumed that the 

agent (axitinib) will be of considerable interest for future testing if the median recurrence-free survival 

is increased by 50% or more (i.e. an RFS hazard ratio of ≥ 1.5). 

Fifty-six centrally reviewed eligible patients are targeted over two years. Upon accrual completion, 

patients will be followed for an additional six months before analysis. The power is approximately 

0.90 for detecting a statistically significant, favorable recurrence-free survival compared to the 

estimated historical benchmark of a 3-month median RFS. This calculation assumes an exponential 

RFS distribution and parameter estimation. 

Assuming a 10% central review ineligibility rate, approximately 62 patients will be enrolled 




Results 

Pending activation 

Developing Approved Concept 

S0903: A Randomized Phase II Study Evaluating Carboplatin/paclitaxel Compared with 

Carboplatin/paclitaxel and Everolimus in Patients with Epithelial Ovarian, Fallopian Tube, or 

Primary Peritoneal Cancer in First Relapse. 

Schema 

Screening 

Randomization 

RAD001 for 14 days 

as monotherapy (Days 

-14 to 0) 

Carboplatin+Paclitaxel 

q21days 

(day 0 and following) 

Carboplatin+Paclitaxel 

q21days + RAD001 

continuous daily therapy 

(day 0 and following) 

Rationale 

The ICON-4 trial has established carboplatin and paclitaxel as a preferred therapy in patients 

with platinum-sensitive relapses of epithelial ovarian or primary peritoneal carcinoma(1). The 

combination of carboplatin and paclitaxel demonstrated a survival advantage over single 

agent carboplatin in this 800 patient trial. Approximately 40% of ovarian cancers have 

increased AKT2 activity in comparison with normal ovarian epithelial cells(2). Studies using a 

phospho-specific anti-AKT antibody (SER473) that recognizes all three activated forms (AKT1, 

AKT2, AKT3) showed strong immunohistological staining in 68% of ovarian carcinomas. 

Downstream of AKT, phospho-mTOR and phospho-GSK3β correlate with AKT activation 

status in greater than 80% of ovarian carcinomas examined validating activation of the 




PI3K/AKT pathway. Pharmacologic agents that inhibit downstream targets of such pathways 

such as mTOR might preferentially kill tumor cells that have dependence on AKT activity for 

survival that is not shared by normal cells. Everolimus targets mTOR, and has been shown to 

potentiate the activity of platinum in ovarian cancer(3); as such it is a rational partner with 

carboplatin and paclitaxel. The ICON-4 trial included a large proportion of patients (about 

60%) who had not previously received a taxane. As platinum in combination with a taxane 

now represents the standard of care for initial treatment of ovarian carcinoma, this trial does 

not provide a reasonable historical control for activity of carboplatin and paclitaxel in the 

second-line setting. For this reason, we propose a randomized Phase II design to determine 

whether the addition of everolimus provides additional benefit to carboplatin and paclitaxel in 

the treatment of recurrent ovarian cancer. 

Objectives 

Primary Objectives: 

• To determine whether RAD001 in addition to carboplatin and paclitaxel increases the 

duration of progression-free survival in patients with recurrent platinum sensitive 

epithelial ovarian or primary peritoneal carcinoma compared to chemotherapy alone. 

• To evaluate the clinical response rate (partial and complete responses as defined by 

RECIST criteria) in each arm. 

Secondary Objectives: 

• To determine the overall survival in patients with recurrent platinum sensitive epithelial 

ovarian or primary peritoneal carcinoma treated with carboplatin/paclitaxel and 

RAD001 compared to chemotherapy alone. 

• To determine the nature and degree of toxicity of carboplatin/paclitaxel and RAD001 in 

patients with recurrent platinum sensitive epithelial ovarian or primary peritoneal 

carcinoma compared to chemotherapy alone. 


Progression-free survival (PFS) will be the primary endpoint for this phase II study. Based on the 

results of ICON4 (Lancet 2003; 361:2099-2106), the control median PFS is estimated to be 13 

months. With a PFS hazard ratio of 1.5, a one-sided alpha of 0.20 and 108 centrally reviewed 

patients eligible for analysis, the power to detect a positive signal for further investigating the 

experimental treatment is approximately 0.86. Assuming a 10% ineligibility rate, 120 enrollments will 

be targeted. This calculation assumes a 3-year enrollment period and 2 additional years’ follow-up 

before analysis. 

Results 

Pending activation. This study is subject to review by the Gynecologic Cancer Steering 

Committee of the NCI. 




VISION 

There are several important goals of the reactivated SWOG Gynecologic Committee, 

including: 

1. To conduct in the United States more high quality investigator-initiated clinical 

trials that address relevant issues in the management of female pelvic 

malignancies (cancers of the ovary, endometrium and cervix) and that may 

form the basis for future investigative efforts in these malignancies. 

2. To increase the participation of outstanding clinical investigators from multiple 

institutions (SWOG-based and non-SWOG-based) in the development of an 

outstanding clinical research agenda in the area of female pelvic malignancies. 

3. To increase availability of well-designed clinical trials for patients with female 

pelvic malignancies. 

4. To utilize novel therapeutic strategies, including use of innovative study designs 

(e.g., phase I - II and randomized phase II trials; use of non-overall survival 

endpoints; biological-marker based treatment selection and trial endpoints, etc.) 

5. To perform studies examining novel management strategies in areas where 

there is a genuinely extremely serious unmet need (e.g., development of a 

biologically active therapeutic regimen in platinum-resistant cervix cancer) 

6. To perform studies in settings were there is currently limited (or no) 

pharmaceutical company interest, but where highly clinically-relevant questions 

exist (e.g., future chemotherapy for a patient experiencing a serious platinum 

hypersensitivity reaction). 

7. To participate in national and international-based efforts so that studies that 

address important clinical questions in the management of gynecologic cancers 

can be completed in a timely fashion. 

8. To collect, where relevant and feasible in this cooperative group setting, 

clinically annotated biological samples (tumor, normal tissue) that can be 

subsequently utilized to explore potentially relevant translational research 

questions. 

It is important to recognize that the initial trials to be developed by the SWOG Gynecologic 

Committee will be modest in size (single arm or randomized phase 2). In addition, the studies 

will address questions that are medically-based (e.g., no requirement for surgical 

cytoreduction), and in general will have limited documentation of surgical-staging or detailed 

pathologic review (e.g., tumor grading). These practical considerations will allow for increased 

participation of all investigators in the SWOG, which is a medically-based group, as well as 

Special Members. Further, it is planned that eligibility criteria will be as non-restrictive as 

possible, which will hopefully permit more timely trial accrual, permit more patients to be given 

the opportunity to participate, and will allow for a less restrictive interpretation of the potential 

relevance of the trial results. 

It is possible that in the future the SWOG Gynecologic Committee may be positioned to 

perform randomized phase III trials, but such an effort will only be considered if accrual onto 

phase II studies led by the Group suggests an expansion into the realm of phase III studies 

will be successful. 

A unique and exciting benefit for the Gynecologic Committee that the special membership 

offers is our ability to harmonize with all investigators, whether affiliated with a SWOG 

institution or not. This enables the Gynecologic Committee to conduct innovative research 




and trials with a much broader range of investigators, Cancer Centers, and the SPORES at 

these centers (e.g. M.D. Anderson, Dana-Farber, Fox Chase, Fred Hutchinson, and John 

Hopkins), which greatly enhances our ability to conduct translational research. 

Finally, it is in the vision of the committee to attempt to actively engage young clinical 

investigators interested in critically-relevant and persistently vexing issues in the management 

of female-pelvic cancers to help them launch successful and productive cancers in this arena. 

PUBLICATIONS 

SOUTHWEST ONCOLOGY GROUP 

PUBLICATIONS LIST 

GYNECOLOGIC COMMITTEE 

2003-2008 

(includes 2002 pubs not listed in previous competing renewal application) 

________________________________________________________________________________________________________ 

DATE 

DATE 

PROTOCOL PROTOCOL PROTOCOL 

NUMBER PUBLICATIONS (TITLE & CITATION) ACTIVATED CLOSED 

________________________________________________________________________________________________________ 

GYN MANUSCRIPTS PUBLISHED/PRESENTED (2002) 

8412 Improved therapeutic index of carboplatin plus 11/25/85 05/01/89 

cyclophosphamide versus cisplatin plus 

cyclophosphamide: Final report by the Southwest 

Oncology Group of a phase III randomized trial in 

stages III and IV ovarian cancer. DS Alberts, S Green, 

EV Hannigan, R O'Toole, D Stock-Novack, P Anderson, 

EA Surwit, VK Malviya, WA Nahhas, CJ Jolles. 

Classic Papers and Current Comments 7(1):41-52, 2002. 

8797 Concurrent chemotherapy and pelvic radiation therapy 9/1/90 12/15/96 

compared with pelvic radiation therapy alone as adjuvant 

therapy after radical surgery in high-risk early-stage cancer 

of the cervix. WA Peters III, PY Liu, RJ Barrett II, RJ Stock, 

BJ Monk, JS Berek, L Souhami, P Grigsby, W Gordon Jr, 

DS Alberts. Classic Papers and Current Comments 7(1): 

174-181, 2002. 

9227 Phase III trial of standard-dose intravenous cisplatin plus 12/15/92 4/3/95 

paclitaxel versus moderately high-dose carboplatin 

follow by intravenous paclitaxel and intraperitoneal 

cisplatin in small volume stage III ovarian carcinoma: 

an Intergroup study of the Gynecologic Oncology Group, 

Southwestern Oncology Group, and Eastern Cooperative 

Oncology Group. M Markman, BN Bundy, DS Alberts, 

JM Fowler, DL Clark-Pearson, LF Carson, S Wadler, 

J Sickel. Classic Papers and Current Comments 7(1):92-99, 

2002. 


S9047 Adjuvant treatment for early ovarian cancer: a 1/1/91 3/14/94 

randomized phase III trial of intraperitoneal 32P or 

intravenous cyclophosphamide and cisplatin – a 

gynecologic oncology group study. RC Young, 

MF Brady, RK Nieberg, HJ Long, AR Mayer, 

SS Lenz, J Hurteau, DS Alberts. Journal of Clinical 

Oncology 21 (23):4350-4355, 2003. PMID: 14645424 

S9238 Phase III trial of paclitaxel at two dose levels, the higher 1/15/93 2/6/95 

dose accompanied by filgrastim at two dose levels in 




platinum-pretreated epithelial ovarian cancer: an intergroup 

study. GA Omura, MF Brady, KY Look, HE 

Averette, JE Delmore, HJ Long, S Wadler, G Spiegel, 

SG Arbuck. Journal of Clinical Oncology 21(15):2810- 

2814, 2003. PMID: 12807937 

S9618 Phase II trial of single agent carboplatin followed by dose 10/1/96 9/15/99 

intense paclitaxel, followed by maintenance paclitaxel therapy 

in stage IV ovarian, fallopian tube and peritoneal cancers: a 

Southwest Oncology Group trial. M Markman, T Glass, HO 

Smith, KD Hatch, GR Weiss, SA Taylor, JW Goodwin, DS Alberts. 

Gynecologic Oncology 88:282-288, 2003. PMID: 12648576 

S9619 Combined intraperitoneal and intravenous chemotherapy for 5/15/96 5/15/98 

women with optimally debulked ovarian cancer: Results 

from an Intergroup Phase II trial. ML Rothenberg, 

PY Liu, PS Braley, SP Wilczynski, EV Hannigan, S Wadler, 

G Stuart, C Jiang, M Markman, DS Alberts. 

Journal of Clinical Oncology 21(7):1313-1319, 2003. 

PMID: 12663720 

S9701 Phase III randomized trial of 12 versus 3 months of 11/15/97 12/1/01 

maintenance paclitaxel in patients with advanced ovarian 

cancer after complete response to platinum and 

paclitaxel-based chemotherapy: a Southwest Oncology 

Group and Gynecologic Oncology Group trial. M Markman, 

PY Liu, S Wilczynski, B Monk, LJ Copeland, RD Alvarez, 

C Jiang, D Alberts. Journal of Clinical Oncology 

21(13):2460-2465, 2003. PMID: 12829663 

GYN ABSTRACTS PUBLISHED/PRESENTED (2003) 

S9318 Recombinant human erythropoietin (EPO) as an adjunct to 12/15/94 3/1/99 

radiation therapy and cisplatin for stage IIB-IVA carcinoma 

of the cervix: a Southwest Oncology Group study. RS Lavey, 

PY Liu, BE Greer, WR Robinson III, CC Pui, RB Wynn, ME 

Conrad, C Jiang, M Markman, DS Alberts. Int Journal of 

Rad Onc Bio Phy 57(2) Suppl:S190-S191 (#110), 2003. 

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T7X- 

49FGM43- 

51&_user=99318&_coverDate=10%2F01%2F2003&_alid=816267094&_rdoc 

=269&_fmt=high&_orig=search&_cdi=5070&_st=13&_docanchor=&view=c& 

_ct=790&_acct=C000007678&_version=1&_urlVersion=0&_userid=99318& 

md5=ba56b22b09460adef7ee6547f4b09492 


9106 Randomized phase II trial of two high dose chemotherapy 7/1/93 11/15/97 

regimens with stem cell transplantation for the treatment of 

advanced ovarian cancer in first remission or chemosensitive 

relapse: a Southwest Oncology Group study. PJ Stiff, 

EJ Shpall, PY Liu, SP Wilczynski, NS Callander, SA Scudder, 

AR Jazieh, W Samlowski, J McCoy, DS Alberts. 


9318/9405 Recombinant human erythropoietin as an adjunct to 12/15/94 3/1/99 

radiation therapy and cisplatin for stage IIB-IVA carcinoma 

of the cervix: a Southwest Oncology Group study. 

RS Lavey, PY Liu, BE Greer, WR Robinson, PC Chang, 

RB Wynn, ME Conrad, C Jiang, M Markman, DS Alberts. 


9324 Phase II trial of vinorelbine for relapsed ovarian cancer. 3/15/95 7/1/97 

A Southwest Oncology Group study. ML Rothenberg, 




PY Liu, S Wilczynski, WA Nahhas, GL Winakur, C Jiang, 

CM Moinpour, B Lyons, GR Weiss, JH Essell, HO Smith, 

M Markman, DS Alberts. Gynecologic Oncology 95:506-512, 

2004. PMID: 15581954 

9326 Long-term follow-up of a phase II trial of oral altretamine for 9/1/93 7/1/97 

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. PMID: 15086720 


8797 Rethinking the use of chemotherapy and radiation after 9/1/90 12/15/96 

radical hysterectomy: a clinical-pathologic analysis of 

SWOG 8797/GOG 109. SS Im, BJ Monk, J Wang, 

RJ Stock, WA Peters III, PY Liu, RJ Barrett II, JS Berek, 

L Souhami, P Grisby, W Gordon, DS Alberts. 

Gynecologic Oncology 92:396 (#8), 2004. 

http://www.sciencedirect.com/science?_ob=PublicationURL&_tockey=%23TOC 

%236814%232004%23999079998%23476818%23FLA%23&_cdi=6814&_pub 

Type=J&_auth=y&_acct=C000007678&_version=1&_urlVersion=0&_userid=99 

318&md5=74f1708f66e7a96f778a7115b4fd0ed0 

*S9717 Tirapazamine plus cisplatin in advanced or recurrent 8/15/98 8/15/00 

squamous or adenosquamous carcinoma of the uterine 

cervix: a phase II study of the Southwest Oncology Group 

(SWOG). HO Smith, C Jiang, GR Weiss, AV Hallum III, 

PY Liu, AM Miller, DR Gandara, M Markman, DS Alberts. 

Gynecologic Oncology 92:416 (#49), 2004. 


S9720 Paclitaxel and carboplatin with amifostine in advanced, 2/15/98 7/15/01 

recurrent, or refractory endometrial adenocarcinoma: a 

phase II study of the Southwest Oncology Group. 

SA Scudder, PY Liu, SP Wilcynski, HO Smith, C Jiang, 

AV Hallum III, GB Smith, EV Hannigan, M Markman, 

DS Alberts. Gynecologic Oncology 96:610-615, 2005. 

PMID: 15721401 


*S9701 Relationship between pretreatment CA-125 level and 11/15/97 12/1/01 

risk of relapse in advanced ovarian cancer (AOC) patients 

in a complete clinical response (CCR) who received 

“maintenance therapy”. PY Liu, DS Alberts, BJ Monk, 

M Brady, M Markman. Proc of the American Society 

of Clinical Oncology, Journal of Clinical Oncology 

23(16S):458S (#5013), 2005. 

http://meeting.ascopubs.org/cgi/content/abstract/23/16_suppl/5013?maxtosho 

w=&HITS=10&hits=10&RESULTFORMAT=&fulltext=liu&searchid=1&FIRSTIN 

DEX=0&volume=23&issue=16_suppl&resourcetype=HWCIT 


8412 Significance of early changes in the serum CA-125 antigen 11/25/85 5/1/89 

level on overall survival in advanced ovarian cancer. M 

Markman, M Federico, PY Liu, E Hannigan, D Alberts. 


8790 Randomized trial of adjuvant intraperitoneal alpha-interferon 3/1/88 6/15/99 

in stage III ovarian cancer patients who have no evidence of 




disease after primary surgery and chemotherapy: an intergroup 

study. DS Alberts, EV Hannigan, PY Liu, C Jiang, S Wilczynski, 

L Copeland, M Markman. Gynecologic Oncology 100:133-138, 2006. 

PMID: 16153694 

S9701/9326 Pretreatment CA-125 and risk of relapse in advanced 11/15/97 12/01/01 

ovarian cancer. M Markman, PY Liu, M Rothenberg, 9/1/93 7/1/97 

BJ Monk, M Brady, DS Alberts. Journal of Clinical 

Oncology 24(9):1454-1458, 2006. PMID: 16549840 

S9717 Tirapazamine plus cisplatin in advanced or recurrent 8/15/98 8/15/00 

carcinoma of the uterine cervix: a Southwest Oncology 

Group study. HO Smith, CS Jiang, GR Weiss, AV Hallum III, 

PY Liu, WR Robinson III, PC Cheng, SA Scudder, 

M Markman, DS Alberts. International Journal of 

Gynecological Cancer 16:298-305, 2006. PMID: 

16445649 

G0167 Concurrent endometrial carcinoma in women with a 7/15/01 2/24/03 

biopsy diagnosis of atypical endometrial hyperplasia: 

A Gynecologic Oncology Group Study. CL Trimble, 

J Kauderer, R Zaino, S Silverberg, PC Lim, JJ Burke, 

DS Alberts, J Curtin. Cancer 106(4):812-819, 2006. 

PMID: 16400639 


S9701 A modified CA-125 progression criterion in ovarian cancer 11/15/97 12/01/01 

(OC) patients (pts) receiving maintenance treatment following 

complete clinical response (cCR) to primary therapy. P Liu, 

J Moon, DS Alberts, BJ Monk, M Brady, M Markman. 

Proc of the American Society of Clinical Oncology, 

Journal of Clinical Oncology 24(18S):#5080, 2006. 

http://meeting.ascopubs.org/cgi/content/abstract/24/18_suppl/5080?maxtoshow 

=&HITS=10&hits=10&RESULTFORMAT=&fulltext=liu&searchid=1&FIRSTIND 

EX=10&volume=24&issue=18_suppl&resourcetype=HWCIT 

S9701 Survival (S) of ovarian cancer (OC) patients (pts) treated 11/15/97 12/01/01 

on SWOG 9701/GOG178: 12 versus (v) 3 cycles (c) of 

monthly single-agent paclitaxel (PAC) following attainment 

of a clinically –defined complete response (CR) to platinum 

(PLAT)/PAC. M Markman, PY Liu, S Wilczynski, B Monk, 

LJ Copeland, D Alberts. Proc of the American Society of 

Clinical Oncology, Journal of Clinical Oncology 24(18S): 

#5005, 2006. 


=&HITS=10&hits=10&RESULTFORMAT=&fulltext=markman&searchid=1&FIRS 

TINDEX=0&volume=24&issue=18_suppl&resourcetype=HWCIT 


S9701 An early signal of CA-125 progression for ovarian cancer 11/15/97 12/01/01 

patients receiving maintenance treatment after complete 

clinical response to primary therapy. PY Liu, DS Alberts, 

BJ Monk, M Brady, J Moon, M Markman. Journal of Clinical 

Oncology 25(24):3615-3620, 2007. PMID: 17704410 

S0211 Phase II trial of imatinib mesylate in recurrent, biomarker 4/15/02 01/01/06 

positive, ovarian cancer (Southwest Oncology Group 

Protocol S0211). DS Alberts, PY Liu, SP Wilczynski, A Jang, 

J Moon, JH Ward, JT Beck, M Clouser, M Markman. 

International Journal of Gynecological Cancer 17:784-788, 

2007. PMID: 17343607 





S0200 Phase III randomized trial of pegylated liposomal doxorubicin 8/15/02 12/15/04 

(PLD) plus carboplatin versus carboplatin in platinum-sensitive 

(PS) patients with recurrent epithelial ovarian or peritoneal 

carcinoma after failure of initial platinum-based chemotherapy: 

Southwest Oncology Group Protocol S0200. DS Alberts, 

PY Liu, S Wilczynski, M Clouser, A Lopez, M Lange, V Lanzotti, 

M Markman. Proc of the American Society of Clinical Oncology, 

Journal of Clinical Oncology 25(18S):#5551, 2007. 


=&HITS=10&hits=10&RESULTFORMAT=&fulltext=alberts&searchid=1&FIRST 

INDEX=0&volume=25&issue=18_suppl&resourcetype=HWCIT 

MANUSCRIPTS PUBLISHED/PRESENTED (2008) 

8797 Reducing uncertainties about the effects of chemo- 9/1/90 12/15/96 

radiotherapy for cervical cancer: a systemic review and 

meta-analysis of individual patient data from 18 randomized 

trials. C Vale, JF Tierney, LA Stewart, M Brady, K Dinshaw, 

A Jakobsen, MK Parmar, G Thomas, T Trimble, DS Alberts, 

H Chen, S Cikaric, PJ Eifel, M Garipagaoglu, H Keys, 

N Kantardzic, P Lal, R Lanciano, F Leborgne, V Lorvidhaya, 

H Onishi, RG Pearcey, E Pras, K Roberts, PG Rose, G 

Thomas, CW Whitney. Journal of Clinical Oncology 

26(35):5802-5812, 2008. PMID: 19001332 

S0200 Randomized trial of pegylated liposomal doxorubicin (PLD) 08/15/02 12/15/04 

plus carboplatin versus carboplatin in platinum-sensitive 

(PS) patients with recurrent epithelial ovarian or peritoneal 

carcinoma after failure of initial platinum-based chemotherapy 

(Southwest Oncology Group Protocol S0200). DS Alberts, 

PY Liu, SP Wilczynski, MC Clouser, AM Lopez, DP Michelin, 

VJ Lanzotti, M Markman. Gynecologic Oncology 108:90-94, 

2008. PMID: 17949799 

MANUSCRIPTS SUBMITTED/ACCEPTED (2008) 

S0009 Phase II evaluation of neoadjuvant chemotherapy 3/15/01 2/1/06 

and debulking followed by intraperitoneal chemotherapy 

in women with stage III and IV epithelial ovarian, fallopian 

tube or primary peritoneal cancer: Southwest Oncology 

Group Study S0009. AD Tiersten, PY Liu, HO Smith, SP 

Wilcznyski, WR Robinson, M Markman, DS Alberts. 

Not accepted by Journal of Clinical Oncology; Accepted 

by Gynecologic Oncology, 11/19/08. 

G0182 Evaluation of new platinum-based treatment 8/15/01 9/1/04 

regimens in advanced-stage ovarian cancer, a 

phase III trial of the Gynecologic Cancer Inter- 

Group (GCIC). M Bookman, MF Brady, WP McGuire, 

P Harper, D Alberts, M Friedlander, N Colombo, 

J Fowler, PA Argenta, K DeGeest, D Mutch, 

RA Burger, AM Swart, EL Trimble, C Accario- 

Winslow, L Roth. Accepted by Journal of 

Clinical Oncology, 9/08. 

ABSTRACT PUBLISHED/PRESENTED (2008) 




S0009 Phase II evaluation of neoadjuvant chemotherapy and 3/15/01 2/1/06 

debulking followed by intraperitoneal chemotherapy in 

women with stage III and IV epithelial ovarian, fallopian 

tube or primary peritoneal cancer: Southwest Oncology 

Group study S0009. AD Tiersten, PY Liu, HO Smith, 

SP Wilczynski, WR Robinson, M Markman, DS Alberts. 

Gynecologic Oncology 108(3) Suppl. 1:S3, 2008. 

*Presented

GYNECOLOGIC COMMITTEE - SWOG

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