Trial & Business Updates:

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Priority Lists

Activations

S0001Phase III

Activation

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
Study Coordinator(s)Deborah T. Blumenthal, M.D., Alexander M. Spence, M.D., Keith J. Stelzer, M.D.,Ph.D., Andrew Edward Sloan, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Radiation Oncologists
S0027Phase II

Activation

Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or with Performance Status 2
Study Coordinator(s)Paul J. Hesketh, M.D., Derick H.M. Lau, M.D.,Ph.D., James H. Doroshow, M.D.
ParticipantsMembers, NCORP, Medical Oncologists

Closures

C19801Phase II Intergroup

Permanent Closure (Effective 9/12/01)

A Phase II Study of 506U78 in Patients with Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)
Study Coordinator(s)Steven E. Coutre, M.D., Alison T. Stopeck, M.D.
ParticipantsPathologists, NCORP, Members
Closure Date2001-09-12
S0007Phase II

Temporary Closure effective 8/14/01

Evaluation of 3 Hour Infusion of Paclitaxel Plus Cisplatin and 5-Fluorouracil in Patients with Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Coordinator(s)Maha H.A. Hussain, M.D., Wolfram E. Samlowski, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2003-05-15
SWOG-9411Phase III Intergroup

Memorandum and Permanent Closure effective 8/31/01.

A Phase III Prospective Randomized Trial Comparing Laparoscopic - Assisted Colectomy Versus Open Colectomy for Colon Cancer
Study Coordinator(s)Robert W. Beart, M.D., John Vetto, M.D.
Closure Date2001-08-31

Amendments, Revisions, Memoranda

N9741Phase III Intergroup

Memorandum regarding incorrect numbering of Revision #7

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
N9831Phase III Intergroup

Amendment #1

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S0023Phase III Intergroup

Revision #1

A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetacel followed by Maintenance Therapy with ZD1839 (NSC-715055) or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Study Coordinator(s)Karen Kelly, M.D., Laurie E. Gaspar, M.D., Wilbur A. Franklin, M.D., David R. Gandara, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, NCCTG, NCIC-CTG, CTSU, EPP
S0033Phase III Intergroup

Memorandum

"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
S0107Phase II

Revision #1

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Study Coordinator(s)Robert P. Whitehead, M.D.
ParticipantsMembers, NCORP
S9916Phase III Intergroup

Revision #8

Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
Study Coordinator(s)Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU
S9923Phase II

Memorandum

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

Memorandum

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

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