THE GROUP NEWSLETTER - SWOG

Page 10
DECEMBER 2003
THE GROUP N EWSLETTER
Southwest Oncology Group Protocol Update
from July 15 — November 01, 2003 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 (No Activations 08/01/03, 09/15/03, 10/15/03, and 11/15/03)
S0202, A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine
(NSC-712807) in Patients with Unresectable or Metastatic Gallbladder
or Cholangiocarcinoma. Study Coordinators: Drs. S. Iqbal and H.J.
Lenz. Activation Revision, 09/01/03.
S0221, Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week
Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or
Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-
Positive or High-Risk Node Negative Breast Cancer. Study Coordinators:
Drs. G.T. Budd and H.C.F. Moore. Activation, 11/01/03.
S0222, A Phase II Study of Tirapazamine (NSC-130181)/ Cisplatin/
Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage
Small Cell Lung Cancer. Study Coordinators: Drs. Q.X. Le, S.K.
Williamson, P. Lara and Z. Goldberg. Activation, 09/01/03.
S0230, Phase III Trial of LHRH Analog Administration During Chemotherapy
to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy
in Early Stage, Hormone-Receptor Negative Breast Cancer.
Study Coordinators: Drs. H.C.F. Moore, K.S. Albain. Activation, 10/01/03.
S0301, 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. Activation, 10/01/03.
S0309, Myeloma Specimen Repository Protocol, Ancillary. Study Coordinator:
Dr. J. Epstein. Activation, 11/15/03.
S0322, Single Agent ZD-1839 in Patients With Advanced Head and Neck
Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older
(and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
Study Coordinators: Drs. J. Doroshow and T. Synold. Activation, 08/
15/03.
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.
Activation, 09/01/03.
S0331, A Phase II Trial of STI-571/Imatinib (Gleevec ? ) in Neuroendocrine
Carcinoma of the Skin (Merkel Cell Carcinoma). Study Coordinators:
Drs. W.E. Samlowski, R.J. Tuthill and M.C. Heinrich. Activation, 10/01/03.
S0355, A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-
247550 (NSC-710428D) in Patients with Advanced Malignancies and
Varying Levels of Liver Dysfunction. Study Coordinators: Dr. A. Davies.
Activation,11/01/03.
AEWS0031, Trial of Chemotherapy Intensification Through Interval Compression
in Ewing Sarcoma and Related Tumors, Phase III Intergroup.
Study Coordinator: Dr. Karen H. Albritton. Activation 09/01/03.
CLOSURES (No Closures 10/01/03, 10/15/03, and 11/15/03)
SWOG-9342, A Study of the Late Cardiac Effects of Two Different
Adjuvant Chemotherapy Regimens in Women With Node Negative
Breast Cancer Treated on SWOG-8897. Study Coordinators: Drs. P.
Ganz, K. Albain and L. Hutchins. Permanent Closure, 11/15/03.
SWOG-9442 (T94-0086), Randomized Multi-Institutional Phase III Trial
of BEP and High Dose Chemotherapy Versus BEP Alone in Previously
Untreated Patients With Poor and Intermediate Risk Germ Cell Tumors.
Study Coordinators: Drs. K.A. Margolin, P.J. Stiff and M.F.
Sarosdy. Permanent Closure, 09/08/03.
S9926, Phase II Study of Temozolomide in Unresectable or Metastatic
Gastrointestinal Stromal Tumors (GIST). Study Coordinators: Drs.
M.M. Zalupski and R.A. Kempf. Permanent Closure, 09/01/03.
S0010, A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed
or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL). Study
Coordinators: Drs. S. Coutre, D. Boldt, D. Head and M. Slovak.
Temporary Closure, 11/01/03.
S0013, Evaluation of In Vitro Assays as Predictors of Clinical Outcome in
Patients With Locally Advanced (Stage IIB-IVA) Cervical Carcinoma,
Biologic. Study Coordinator: Dr. R.A. Burger. Permanent Closure,
11/15/03.
S0111, A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC
#710428) (IND 59699) Administered Every 21 Days in Patients With
Hormone Refractory Prostate Cancer. Study Coordinators: Drs.
M.H.A. Hussain and P.N. Lara, Jr. Permanent Closure, 11/15/03).
S0127, A Phase II Study of OSI-774 (NSC 718781) in Unresectable or
Metastatic Adenocarcinoma of the Stomach and Gastroesophageal
Junction. Study Coordinator: Dr. T. Dragovich. Permanent Closure,
08/15/03.
S0227, Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/
Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the
Cervix. Study Coordinators: Drs. H.J. Long and M. Markman. Permanent
Closure, 7/28/03.
C80002, A Phase II Study of Local Excision Alone or Local Excision Plus
Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers.
Study Coordinator: Dr. Morton S. Kahlenberg. Permanent Closure,
8/29/03.
E4397, A Phase II Trial of Preradiation in Multiagent Chemotherapy For
Adults With “Poor Risk” Medulloblastoma, PNET, and Disseminated
Ependymoma. Southwest Oncology Group Study Coordinator: Dr.
G.R. Barger. Permanent Closure, 11/15/03.
G0175, A Randomized Phase III Trial of IV Carboplatin (AUC 6) and
Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Low Dose Paclitaxel
40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2
Q 21 Days X 3 Courses Plus Observation in Patients With Early Stage
Ovarian Carcinoma. Southwest Oncology Group Study Coordinators:
Drs. D.S. Alberts and C. Johnston. Permanent Closure, 8/15/03.
NOTE: Turn to Page 13 for a listing of Southwest Oncology Group-Endorsed CTSU Protocols.