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Priority Lists

Activations

E1303Phase II Intergroup
Phase II Trial of PS-341 (NSC-681239) Followed by the Addition of Doxirubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck
Study Coordinator(s)Madeleine Kane, M.D., Ph.D
ParticipantsMembers, NCORP, Medical Oncologists
S0430Phase II

Activation

Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer
Study Coordinator(s)Anne F. Schott, M.D., Daniel F. Hayes, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

Closures

S0347Phase III

Temporary closure effective 9/1/05

A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With Her-2 Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy – Phase III
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph, Francisco J. Esteva, M.D., Ph.D
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
Closure Date2006-02-01
S9912Phase II

Permanent Closure

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
Closure Date2005-08-15

Amendments, Revisions, Memoranda

N9841Phase III Intergroup

Revision #10

A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, Surgeons, NCORP
S0008Phase III Intergroup

Revision #17

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
S0106Phase III

Revision #3

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
Action CodesER
Study Coordinator(s)Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU
S0108Phase II

Memorandum

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
S0108Phase II

Revision #2

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
S0124Phase III

Memorandum

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
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
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0232Phase III

Memorandum

Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
Action CodesER
Study Coordinator(s)Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0303Phase III

Memorandum

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0312Phase II

Memorandum

A Phase II Study of IV Gemcitabine and Oral Capecitabine in Patients with Advanced Renal Cell Cancer
Study Coordinator(s)Peter J. Van Veldhuizen, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0317Phase II

Revision #2

A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Study Coordinator(s)Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG
S0338Phase II

Revision #3

Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer
Study Coordinator(s)Helen K. Chew, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0400Phase II

Revision #1

A Phase II Study of Depsipeptide (NSC-630176) in Patients with Advanced Transitional Cell Carcinoma of the Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen for Advanced Disease
Study Coordinator(s)Daniel P. Petrylak, M.D., Guru Sonpavde, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, Pathologists
S0412Phase II

Revision #2

A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC-724772, IND-69,896) in Combination with Interferon Alpha 2b in Patients wtih Advanced Renal Cancer
Study Coordinator(s)Christopher W. Ryan, M.D., Tomasz M. Beer, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
S0415Phase II

Revision #1

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
S0418Phase II

Revision #1

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Study Coordinator(s)Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Timothy W. Synold, Pharm. D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S0432Phase II Intergroup

Memorandum

Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 (Tipifarnib, Zarnestra®, NSC-702818)for Previously Untreated Acute Myeloid Leukemia (AML) in Patients of Age 70 or Older.
Action CodesER
Study Coordinator(s)Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, CTSU
SWOG-8949Phase III

Revision #5

A Randomized Comparison of Nephrectomy Followed by Interferon Alpha 2-b (Intron-A) vs. Interferon Alpha 2-b (Intron-A) Alone in Patients with Advanced Renal Cell Carcinoma
Study Coordinator(s)Robert C. Flanigan, M.D., Sydney E. Salmon, M.D.
SWOG-8993Phase II

Revision #15

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.
  • 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