Copy of 2003 Group Newsletter 12 15 - SWOG

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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.
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