Trial & Business Updates:

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Priority Lists

Activations

Closures

CTSU/Z9000Phase II

Permanent Closure

Phase II Study of Adjuvant STI571 (Gleevec TM) Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST)
Study Coordinator(s)Vernon K. Sondak, M.D.
ParticipantsCTSU
Closure Date2003-09-30

Amendments, Revisions, Memoranda

CTSU/E1697Phase III Intergroup

Revision #3

Phase III Randomized Study of Four Weeks of High Dose IFN-alpha2b in Stage T2b N0, T3a-b N0, T4a-b N0, and T1-4, N1a, 2a, 3(Microscopic) Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D.
ParticipantsCTSU
S0030Phase II

Revision #2

Protocol for Assessment of Capecitabine for Advanced Colorectal Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger than 60 Years)
Study Coordinator(s)Heinz- Josef Lenz, M.D., Derek Raghavan, M.D.,Ph.D., Carolyn C. Gotay, Ph.D., Dorothy Coleman, R.N., M.S.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Who Have The Ability To Perform Outpatient Blood Collections For Pharmacology Studies
S0107Phase II

Memorandum

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
S0126Phase II

Revision #7

Phase II Trial of Chronic Oral ZD1839 (Iressa) in Both Previously-Untreated and Previously-Treated Patients with Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Study Coordinator(s)Howard (Jack) West, M.D., Ralph B. Vance, M.D., Wilbur A. Franklin, M.D., Derick H.M. Lau, M.D.,Ph.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0202Phase II

Memorandum

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0213Phase II Pilot

Revision #1 and Revision #2

Pilot Trial of Hyper-CVAD and Methotrexate/ARA C+ Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Study Coordinator(s)Elliot M. Epner, M.D., Ph.D, Thomas P. Miller, M.D., Catherine Spier, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0220Phase II Intergroup

Amendment #1

A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumors)
Study Coordinator(s)Michael J. Kraut, M.D., Katherine M. W. Pisters, M.D., Joshua Sonett, M.D., Charles R. Thomas Jr., M.D., Valerie W. Rusch, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG, NCIC-CTG, ACOSOG, NCCTG, CALGB
S0322Phase I

Amendment #1

Single Agent ZD-1839 in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger), Pharmacology.
Study Coordinator(s)Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D.
ParticipantsLimited: Institutions Listed on the Title Page
S9900Phase III Intergroup

Revision #13

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

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