Priority Lists
Protocol Posting of
Activations
Re-Activation Revision
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. |
Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG |
Activation
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. |
Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Re-Activation 3/22/05
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 Codes | ER |
Study Coordinator(s) | Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Closures
Permanent Closure
Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC #706363) as Initial Consolidation Therapy Followed by Intermittent Tretinoin Maintenance Therapy Versus Observation for Patients with Untreated Acute Promyelocytic Leukemia
Action Codes | ER |
Study Coordinator(s) | Steven E. Coutre, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D. |
Participants | Pathologists, NCORP, Members |
Closure Date | 2005-03-29 |
Permanent Closure
Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)
Study Coordinator(s) | Cynthia Jumper, M.D. |
Participants | CTSU |
Closure Date | 2004-12-28 |
Temporary Closure effective 4/15/05
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. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Closure Date | 2005-12-15 |
Amendments, Revisions, Memoranda
Memorandum
Phase II Pilot Study of Rituximab + CHOP in Patients with Newly Diagnosed Waldenstrom's Macroglobulinemia
Study Coordinator(s) | Gordan Srkalovic, M.D., Ph.D |
Participants | Members, NCORP, Medical Oncologists, Pathologists |
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 Codes | IP, AC, ER |
Study Coordinator(s) | Kim A. Margolin, M.D. |
Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists |
Memorandum
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. |
Participants | Members, Surgeons, NCORP |
Amendment #8
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. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons |
Memorandum
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. |
Participants | Members, Surgeons, NCORP |
Revision #2
A Phase II Study of Observation in Favorable Low Grade Glioma and a Phase III Study of Radiation with or without PCV Chemotherapy in Unfavorable Low-Grade Glioma
Action Codes | NR |
Study Coordinator(s) | Geoffrey R. Barger, M.D., Keith J. Stelzer, M.D.,Ph.D. |
Participants | Members, Medical Oncologists, Pathologists, Radiation Oncologists, NCORP |
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. |
Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG |
Amendment #3
A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) And Autologous Peripheral Blood Stem Cell Supported Transplantation (SCT) For Patients with AL Amyloidosis or High Risk (greater than or equal to Age 70 or Poor Renal Function)Patients With Multiple Myeloma(A BMT Study)
Action Codes | AC, FBR |
Study Coordinator(s) | Vaishali Sanchorawala, M.D., David C. Seldin, M.D.,Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Limited Institutions: BMT Members |
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. |
Participants | Members, NCORP, Medical Oncologists, CTSU Institutions in the United States |
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 Codes | ER |
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 |
Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
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. |
Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists |
Revision #3
Docetaxel and Vinorelbine Plus Filgrastim with Weekly Trastuzumab for HER-2 Positive, Stage IV Breast Cancer, Phase II Pilot
Study Coordinator(s) | Joseph J. Kash, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Amendment #1
A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Coordinator(s) | Quynh-Thu X. Le, M.D., Stephen K. Williamson, M.D., Primo N. Lara, Jr., M.D., Zelanna Goldberg, M.D. |
Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
Amendment #3
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Study Coordinator(s) | Halle C.F. Moore, M.D., Silvana Martino, D.O. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG |
Amendment #3
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. |
Participants | Members, NCORP, Medical Oncologists, CTSU |
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. |
Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients with Clinical T3-T4 Rectal Cancer
Study Coordinator(s) | Charles R. Thomas Jr., M.D., Heinz- Josef Lenz, M.D., Robert P. Whitehead, M.D., James L. Abbruzzese, M.D., Stephen R. Smalley, M.D., Morton S. Kahlenberg, M.D. |
Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists |
Revision #1
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. |
Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists |
Revision #4
Evaluation of CHOP Plus Involved Field Radiotherapy followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE and non-bulky Stages II and IIE, CD20 Positive, High-risk Localized, Aggressive Histologies of Non-Hodgkin's Lymphoma, Phase II
Study Coordinator(s) | Thomas P. Miller, M.D., Louis S. Constine, M.D., B. Dino Stea, M.D.,Ph.D., Catherine Spier, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum
A Phase II Trial of PS-341 (NSC-681239) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer.
Study Coordinator(s) | Primo N. Lara, Jr., M.D., Angela M. Davies, M.D., Paul H. Gumerlock, Ph.D., Wilbur A. Franklin, M.D. |
Participants | Members, NCORP, Medical Oncologists |
Amendment #1
U.S./Canada Sarcoma Intergroup Study of OSI-774 in Malignant Peripheral Nerve Sheath Tumors, Phase II
Study Coordinator(s) | Karen H. Albritton, M.D., R. Lor Randall, M.D., Cheryl Coffin, M.D., Nancy Ratner, Ph.D., Scott Schuetze, M.D.,Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists, CTSU |
Amendment #4
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s) | Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG |
Memorandum
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s) | Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG |
Memorandum
Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
Study Coordinator(s) | Robert P. Whitehead, M.D. |
Participants | Members, NCORP, Medical Oncologists |
Memorandum
"A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)."
Study Coordinator(s) | Angela M. Davies, M.D., Primo N. Lara, Jr., M.D. |
Participants | Members, NCORP, Medical Oncologists |
Amendment #1
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. |
Participants | Members, NCORP, Medical Oncologists, Pathologists |
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. |
Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum
A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
Study Coordinator(s) | Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
Participants | Members, NCORP, Medical Oncologists, CTSU |
Revision #1
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 |
Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
Oxaliplatin Plus Protracted Infusion 5-Fluorouracil and Radiation for Potentially Curable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Action Codes | ER |
Study Coordinator(s) | Lawrence P. Leichman, M.D., Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D., Thomas J. Watson, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D. |
Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons |
Memorandum
Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s) | Philip Gold, M.D. |
Participants | Members, NCORP |
Revision #2
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 Codes | ER |
Study Coordinator(s) | Harry P. Erba, M.D.,Ph.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Revision #8
Lung Cancer Specimen Repository Protocol, Ancillary
Action Codes | NR |
Study Coordinator(s) | Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG |
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