Trial & Business Updates:

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Priority Lists

Activations

Closures

S0027Phase II

Permanent Closure

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
Closure Date2003-07-01
S0126Phase II

Permanent Closure

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
Closure Date2003-07-01

Amendments, Revisions, Memoranda

C89803Phase III Intergroup

Revision #3

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
E2496Phase III Intergroup

Revision

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
E4697Phase III Intergroup

Memorandum

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients with "No Evidence of Disease" after Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Action CodesIP, AC, ER
Study Coordinator(s)Kim A. Margolin, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
S0008Phase III Intergroup

Revision #12

Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Study Coordinator(s)Lawrence E. Flaherty, M.D., John A. Thompson, M.D., Ralph J. Tuthill, M.D., John Vetto, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
S0023Phase III Intergroup

Amendment #3

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
S0023Phase III Intergroup

Revision #8

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
S0026Phase II

Memorandum

Evaluation of Interferon Alpha-2b and Thalidomide in Patients with Disseminated Malignant Melanoma, Phase II
Study Coordinator(s)Laura F. Hutchins, M.D., Joseph I. Clark, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
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
S0114Phase I-II

Memorandum

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers
Study Coordinator(s)Robert B. Montgomery, M.D., Mary L. Disis, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0200Phase III

Revision #1

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
S9915Phase II

Memorandum

A Phase II Study of PN401, 5-FU, and Leucovorin in Unresectable or Metastatic Adenocarcinoma of the Stomach.
Study Coordinator(s)James H. Doroshow, M.D., John S. Macdonald, M.D.
ParticipantsMembers, NCORP
S9922Phase III

Memorandum

A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma
Study Coordinator(s)Mohamad A. Hussein, M.D., James K. Weick, M.D.
ParticipantsNCORP, Members
SWOG-8624Phase III

Memorandum

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma; Comparison of (1) VMCP/VBAP to VAD or VMCPP/VBAPP for Induction; (2) Alpha-2b Interferon or No Therapy for Maintenance; and 3) Alpha-2b Interferon + Dexamethasone for Incomplete or Non-Responders; and (4) VAD Plus Verapamil For Incomplete or Non-Responders on VAD
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Sheikh Saeed, M.D.
SWOG-8993Phase II

Memorandum

Phase II Study of High Dose Melphalan with Hemopoietic Stem Cell Support and GM-CSF in Refractory Multiple Myeloma (MM)
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D.
SWOG-9028Phase III

Memorandum

A Phase III Randomized Trial of Combination Therapy for Multiple Myeloma Comparison of (1) VAD to VAD/ Quinine for Induction with Crossover to VAD/ Quinine for VAD Induction Failures; (2) Alpha-2b Interferon or Alpha-2b Interferon plus Prednisone for Remission Maintenance
Study Coordinator(s)Bart Barlogie, M.D.,Ph.D., Thomas M. Grogan, M.D.
SWOG-9438Phase III

Amendment #8

Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma, A BMT Study, Phase III
Study Coordinator(s)Alexander Fefer, M.D., John A. Thompson, M.D., Patricia K. Lillis-Hearne, M.D.
ParticipantsLimited Institutions: BMT Members

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