Trial & Business Updates:

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Priority Lists

Activations

S0101Phase II
A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.
Study Coordinator(s)Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0108Phase II
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

Closures

Amendments, Revisions, Memoranda

C89803Phase III Intergroup

Memo (Confirmation of Randomization Form included)

A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC-616348) Plus Fluorouracil/Leucovorin (5FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection For Patients With Stage III Colon Cancer.
Study Coordinator(s)Alexander Hantel, M.D.
ParticipantsPathologists, NCORP, Members
C9581Phase III Intergroup

SWOG Revision #5 regarding CALGB Update #16.

Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler - Coller B2) Adenocarcinoma of the Colon.
Study Coordinator(s)R.L. Martino, M.D.
ParticipantsMembers, Surgeons, Pathologists, NCORP
E3695Phase III Intergroup

Revision #6

A Randomized Phase III Trial of Concurrent Biochemotherapy with Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon a-2b versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients with Metastatic Malignant Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsMedical Oncologists, NCORP, Members
S0003Phase III

Revision #2

Randomized Phase III Trial of Carboplatin and Paclitaxel plus Tirapazamine versus Carboplatin and Paclitaxel in Patients with Advanced Non-Small Cell Lung Cancer Cisplatin, Paclitaxel, Tirapazamine vs. Cisplatin, Paclitaxel Specimen submission per S9925
Study Coordinator(s)Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, EPP, CTSU
S0009Phase II

Revision #1

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer
Study Coordinator(s)Amy D. Tiersten, M.D., Harriet O. Smith, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Surgeons
S0033Phase III Intergroup

Revision #3

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S9701Phase III

Amendment #11

Phase III Randomized Trial of 12 Months VS 3 Months of Paclitaxel in Patients with Advanced Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (Intergroup)
Study Coordinator(s)Maurie Markman, M.D., Bradley J. Monk, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, Pathologists, Surgeons, GOG, NCORP
S9900Phase III Intergroup

Revision #6

A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC).
Study Coordinator(s)Paul A. Bunn Jr., M.D., Katherine M. W. Pisters, M.D., Wilbur A. Franklin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Surgeons, CTSU, ECOG, NCCTG, RTOG, ACOSOG, NCIC-CTG
S9912Phase II

Revision #3

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
S9923Phase II

Memo regarding ADR

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Colorectal Cancer.
Study Coordinator(s)Robert P. Whitehead, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9924Phase II

Memo regarding ADR

A Phase II Trial of R115777 (NSC #70818) in Patients with Advanced Pancreas Cancer.
Study Coordinator(s)John S. Macdonald, M.D., Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S9927Phase III Intergroup

Memorandum / Revision #2

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes, Phase III
Study Coordinator(s)Lori J. Pierce, M.D.
ParticipantsMedical Oncologists, Radiation Oncologists, Surgeons, NCCTG, RTOG, ACOSOG, ECOG, CALGB, NCORP, Members, NCIC-CTG, NSABP
SWOG-9237Phase II

Memorandum

Evaluation of Topotecan in Resistant and Relapsing Multiple Myeloma, Phase II
Study Coordinator(s)Eric H. Kraut, M.D.

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