Trial & Business Updates:

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Priority Lists

Activations

CTSU/Z9000Phase II
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
CTSU/Z9001Phase II
A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec TM) versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)
Study Coordinator(s)John Vetto, M.D.
ParticipantsCTSU
E8897Intergroup

Activation

Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology with Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Study Coordinator(s)Craig R. Nichols, M.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists
S0213Phase II Pilot

Activation Amendment

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

Closures

Amendments, Revisions, Memoranda

E2496Phase III Intergroup

Amendment #3

Randomized Phase III Trial of ABVD Versus Stanford V +/- Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin’s Disease with 0-2 Risk Factors
Study Coordinator(s)Richard I. Fisher, M.D.
ParticipantsMembers, Medical Oncologists, Radiation Oncologists, Pathologists, NCORP
JBR10Phase III Intergroup

Memorandum

A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation
Study Coordinator(s)Robert B. Livingston, M.D.
ParticipantsMembers, Medical Oncologists, Pathologists, Surgeons, NCORP
S0007Phase II

Revision #1

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
S0012Phase III

Amendment #2

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
S0022Phase II

Memorandum

Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Study Coordinator(s)Raja Mudad, M.D., FACP, Laurie E. Gaspar, M.D., R. Chapman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0023Phase III Intergroup

Revision #7

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
S0027Phase II

Revision #6

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
S0120Biologic

Revision #2

A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasma Proliferative Disorders
Study Coordinator(s)Madhav V. Dhodapkar, M.D., Bart Barlogie, M.D.,Ph.D., John D. Shaughnessy, Jr., Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0126Phase II

Revision #4

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
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0204Phase II

Revision #2

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)
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
S0211Phase II

Revision #2

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
S9912Phase II

Amendment #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
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