Trial & Business Updates:

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Priority Lists

Activations

S0226Phase III

Activation

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
Study Coordinator(s)Rita S. Mehta, M.D., Kathy Albain, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S0303Phase III

Activation

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(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU

Closures

Permanent Closure

Phase III Randomized Trial of Fludarabine and Cyclophosphamide versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia.
Study Coordinator(s)Mohamad A. Hussein, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2004-03-19
S0000Phase III

Permanent Closure effective 6/24/04

Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Study Coordinator(s)Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D.
ParticipantsInstitutions listed in protocol Appendix 19.5
Closure Date2004-06-24
S0301Phase II

Temporary Closure

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 Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., Alan F. List, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2006-12-15

Amendments, Revisions, Memoranda

JPR3Phase III Intergroup

Amendment #3

Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate
Action CodesER
Study Coordinator(s)Gregory P. Swanson, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members
R9802Phase II Intergroup

Revision #1

A Phase II Study of Observation in Favorable Low Grade Glioma and a Phase III Study of Radiation with or without PCV Chemotherapy in Unfavorable Low-Grade Glioma
Action CodesNR
Study Coordinator(s)Geoffrey R. Barger, M.D., Keith J. Stelzer, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, Pathologists, Radiation Oncologists, NCORP
R9813Phase IIb

Revision #1

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0012Phase III

Revision #4

A Comparative Randomized Study of Standard Doxorubicin And Cyclophosphamide Followed by Weekly Paclitaxel Vs. Weekly Doxorubicin And Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory And Locally Advanced Breast Cancer
Study Coordinator(s)Georgiana K. Ellis, M.D., Robert B. Livingston, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, EPP, CTSU
S0029Phase II

Revision #2

Single Agent Docetaxel For Metastatic Breast Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
Study Coordinator(s)Silvana Martino, D.O., Dorothy Coleman, R.N., M.S., Carolyn C. Gotay, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0108Phase II

Memorandum

Bevacizumab (rhuMAb) (NSC 704865) Therapy For Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Thomas M. Grogan, M.D., William T. Bellamy, R. Ph.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0109Phase II

Memorandum

A Phase II Study of Flavopiridol (NSC-649890) 1 Hour Bolus Days 1-3 Q 21 Days in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0111Phase II

Memorandum

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 Coordinator(s)Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Wael A. Sakr, M.D., Michael A. Tainsky, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0204Phase II

Memorandum

A Phase II Trial of Thalidomide/Dexamethasone Induction Followed by Tandem Melphalan Transplant and Prednisone/Thalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients, (A BMT Study)
Action CodesNR
Study Coordinator(s)Mohamad A. Hussein, M.D., John D. Shaughnessy, Jr., Ph.D., James A. Waldron, M.D.,Ph.D., Jeffrey A. Zonder, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Limited Institutions: BMT Members
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0207Phase II

Memorandum

Phase II Study of Arsenic Trioxide in Male Patients with Refractory Germ Cell Malignancies
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons
S0211Phase II

Revision #4

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
S0306Phase II

Revision #1

Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium
Study Coordinator(s)Tomasz M. Beer, M.D., Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons
S0313Phase II

Revision #1

Evaluation of CHOP Plus Involved Field Radiotherapy followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE and non-bulky Stages II and IIE, CD20 Positive, High-risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II
Study Coordinator(s)Thomas P. Miller, M.D., Louis S. Constine, M.D., B. Dino Stea, M.D.,Ph.D., Catherine Spier, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0317Phase II

Memorandum

A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Study Coordinator(s)Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG
S9630Phase III Intergroup

Revision #12

A Randomized Comparison of Medroxyprogesterone Acetate (MPA) and Observation For Prevention of Endometrial Pathology in Postmenopausal Breast Cancer Patients Treated with Tamoxifen
Study Coordinator(s)Ronald K. Potkul, M.D., Caryl G. Salomon, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CALGB, NCORP

Other New Items

  • IP - Pts Must Be Informed
  • AC - Consent Must Be Amended
  • CBR - No Registration Allowed until IRB Review
  • RC - Formal Re-consent Required
  • FBR - Full Board Review Required
  • ER - Expedited Review Acceptable
  • NR - No IRB Review Required