Trial & Business Updates:

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Priority Lists

Activations

Activation

A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Flourouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Julie R. Gralow, M.D.
ParticipantsCTSU

Closures

R9704Phase III

Permanent Closure Effective 7/26/02

A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma
Study Coordinator(s)John S. Macdonald, M.D.
ParticipantsMembers, Surgeons, Radiation Oncologists, NCORP

Amendments, Revisions, Memoranda

G0175Phase III Intergroup

Revision #3 and Revision #4

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.
Study Coordinator(s)Carolyn M. Johnston, M.D.
ParticipantsMembers, NCORP
G0182Phase III Intergroup

Revision #4

A Phase III Randomized Trial of Paclitaxel and Carboplatin Versus Triplet or Sequential Doublet Combinations in Patients with Epithelial Ovarian or Primary Peritoneal Carcinoma.
Study Coordinator(s)Amy D. Tiersten, M.D.
ParticipantsNCORP, Members, Surgeons, Pathologists
N9741Phase III Intergroup

Amendment #2

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, Surgeons, NCORP
N9841Phase III Intergroup

Memorandum

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0111Phase II

Revision #8

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
S9912Phase II

Revision #8

Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study Coordinator(s)Harriet O. Smith, M.D., Amy D. Tiersten, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Surgeons, Pathologists, 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