THE GROUP NEWSLETTER - SWOG
THE GROUP NEWSLETTER - SWOG
THE GROUP NEWSLETTER - SWOG
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Page 10<br />
DECEMBER 2003<br />
<strong>THE</strong> <strong>GROUP</strong> N EWSLETTER<br />
Southwest Oncology Group Protocol Update<br />
from July 15 — November 01, 2003 Mailings<br />
This PROTOCOL UPDATE serves as reference for protocol activity during the stated period. When noting Temporary Closures and Reactivated Protocols, bear<br />
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<br />
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<br />
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.<br />
ACTIVATIONS (No Activations 08/01/03, 09/15/03, 10/15/03, and 11/15/03)<br />
S0202, A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine<br />
(NSC-712807) in Patients with Unresectable or Metastatic Gallbladder<br />
or Cholangiocarcinoma. Study Coordinators: Drs. S. Iqbal and H.J.<br />
Lenz. Activation Revision, 09/01/03.<br />
S0221, Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week<br />
Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or<br />
Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-<br />
Positive or High-Risk Node Negative Breast Cancer. Study Coordinators:<br />
Drs. G.T. Budd and H.C.F. Moore. Activation, 11/01/03.<br />
S0222, A Phase II Study of Tirapazamine (NSC-130181)/ Cisplatin/<br />
Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage<br />
Small Cell Lung Cancer. Study Coordinators: Drs. Q.X. Le, S.K.<br />
Williamson, P. Lara and Z. Goldberg. Activation, 09/01/03.<br />
S0230, Phase III Trial of LHRH Analog Administration During Chemotherapy<br />
to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy<br />
in Early Stage, Hormone-Receptor Negative Breast Cancer.<br />
Study Coordinators: Drs. H.C.F. Moore, K.S. Albain. Activation, 10/01/03.<br />
S0301, A Phase II Study of Induction With Daunorubicin, Cytarabine, and<br />
Cyclosporine All By Continuous IV Infusion for Previously Untreated<br />
Non-M3 Acute Myeloid Leukemia (AML) in Patients of Age 56 or Older.<br />
Study Coordinators: Drs. T.R. Chauncey, A.F. List, C.L. Willman, M.L.<br />
Slovak and D.R. Head. Activation, 10/01/03.<br />
S0309, Myeloma Specimen Repository Protocol, Ancillary. Study Coordinator:<br />
Dr. J. Epstein. Activation, 11/15/03.<br />
S0322, Single Agent ZD-1839 in Patients With Advanced Head and Neck<br />
Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older<br />
(and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.<br />
Study Coordinators: Drs. J. Doroshow and T. Synold. Activation, 08/<br />
15/03.<br />
S0327, A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-<br />
Treated Extensive Stage Small Cell Lung Cancer. Study Coordinators:<br />
Drs. P.N. Lara, Jr., A.M. Davies, P.H. Gumerlock and W.A. Franklin.<br />
Activation, 09/01/03.<br />
S0331, A Phase II Trial of STI-571/Imatinib (Gleevec ? ) in Neuroendocrine<br />
Carcinoma of the Skin (Merkel Cell Carcinoma). Study Coordinators:<br />
Drs. W.E. Samlowski, R.J. Tuthill and M.C. Heinrich. Activation, 10/01/03.<br />
S0355, A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-<br />
247550 (NSC-710428D) in Patients with Advanced Malignancies and<br />
Varying Levels of Liver Dysfunction. Study Coordinators: Dr. A. Davies.<br />
Activation,11/01/03.<br />
AEWS0031, Trial of Chemotherapy Intensification Through Interval Compression<br />
in Ewing Sarcoma and Related Tumors, Phase III Intergroup.<br />
Study Coordinator: Dr. Karen H. Albritton. Activation 09/01/03.<br />
CLOSURES (No Closures 10/01/03, 10/15/03, and 11/15/03)<br />
<strong>SWOG</strong>-9342, A Study of the Late Cardiac Effects of Two Different<br />
Adjuvant Chemotherapy Regimens in Women With Node Negative<br />
Breast Cancer Treated on <strong>SWOG</strong>-8897. Study Coordinators: Drs. P.<br />
Ganz, K. Albain and L. Hutchins. Permanent Closure, 11/15/03.<br />
<strong>SWOG</strong>-9442 (T94-0086), Randomized Multi-Institutional Phase III Trial<br />
of BEP and High Dose Chemotherapy Versus BEP Alone in Previously<br />
Untreated Patients With Poor and Intermediate Risk Germ Cell Tumors.<br />
Study Coordinators: Drs. K.A. Margolin, P.J. Stiff and M.F.<br />
Sarosdy. Permanent Closure, 09/08/03.<br />
S9926, Phase II Study of Temozolomide in Unresectable or Metastatic<br />
Gastrointestinal Stromal Tumors (GIST). Study Coordinators: Drs.<br />
M.M. Zalupski and R.A. Kempf. Permanent Closure, 09/01/03.<br />
S0010, A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed<br />
or Refractory Non T-Cell Acute Lymphoblastic Leukemia (ALL). Study<br />
Coordinators: Drs. S. Coutre, D. Boldt, D. Head and M. Slovak.<br />
Temporary Closure, 11/01/03.<br />
S0013, Evaluation of In Vitro Assays as Predictors of Clinical Outcome in<br />
Patients With Locally Advanced (Stage IIB-IVA) Cervical Carcinoma,<br />
Biologic. Study Coordinator: Dr. R.A. Burger. Permanent Closure,<br />
11/15/03.<br />
S0111, A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC<br />
#710428) (IND 59699) Administered Every 21 Days in Patients With<br />
Hormone Refractory Prostate Cancer. Study Coordinators: Drs.<br />
M.H.A. Hussain and P.N. Lara, Jr. Permanent Closure, 11/15/03).<br />
S0127, A Phase II Study of OSI-774 (NSC 718781) in Unresectable or<br />
Metastatic Adenocarcinoma of the Stomach and Gastroesophageal<br />
Junction. Study Coordinator: Dr. T. Dragovich. Permanent Closure,<br />
08/15/03.<br />
S0227, Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/<br />
Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the<br />
Cervix. Study Coordinators: Drs. H.J. Long and M. Markman. Permanent<br />
Closure, 7/28/03.<br />
C80002, A Phase II Study of Local Excision Alone or Local Excision Plus<br />
Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers.<br />
Study Coordinator: Dr. Morton S. Kahlenberg. Permanent Closure,<br />
8/29/03.<br />
E4397, A Phase II Trial of Preradiation in Multiagent Chemotherapy For<br />
Adults With “Poor Risk” Medulloblastoma, PNET, and Disseminated<br />
Ependymoma. Southwest Oncology Group Study Coordinator: Dr.<br />
G.R. Barger. Permanent Closure, 11/15/03.<br />
G0175, A Randomized Phase III Trial of IV Carboplatin (AUC 6) and<br />
Paclitaxel 175 mg/m2 Q 21 Days X 3 Courses Plus Low Dose Paclitaxel<br />
40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2<br />
Q 21 Days X 3 Courses Plus Observation in Patients With Early Stage<br />
Ovarian Carcinoma. Southwest Oncology Group Study Coordinators:<br />
Drs. D.S. Alberts and C. Johnston. Permanent Closure, 8/15/03.<br />
NOTE: Turn to Page 13 for a listing of Southwest Oncology Group-Endorsed CTSU Protocols.