Priority Lists
Protocol Posting of
Activations
Closures
Temporary Closure effective 9/23/10
Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid®) Alone and in Combination with Epoetin Alfa (Procrit®) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Action Codes | ER |
Study Coordinator(s) | Charles Schiffer, M.D. |
Participants | CTSU |
Temporary Closure effective 10/7/10
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
Action Codes | ER |
Study Coordinator(s) | Philip Gold, M.D. |
Participants | CTSU |
Closure Date | 2011-02-11 |
Permanent Closure: Effective November 1, 2010
A Prospective Randomized Phase III Trial Comparing Consolidation Therapy with or without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
Action Codes | ER |
Study Coordinator(s) | Jacek Pinski, M.D. |
Participants | CTSU |
Closure Date | 2010-11-01 |
Permanent Closure effective 11/1/10
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 | ER |
Study Coordinator(s) | Vaishali Sanchorawala, M.D., David C. Seldin, M.D.,Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Limited Institutions: BMT Members |
Permanent Closure effective 11/1/10
A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
Action Codes | ER |
Study Coordinator(s) | Christopher D. Lao, M.D., M.P., John Fruehauf, M.D.,Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Closure Date | 2010-11-01 |
Amendments, Revisions, Memoranda
Memorandum - FDA Data Submission/Inst. Audits
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 |
Memorandum - Clodronate Safety Reports
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Action Codes | ER |
Study Coordinator(s) | Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU |
Memorandum - Iodine-131 Labeled Tositumomab Shipments
Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
Action Codes | NR |
Study Coordinator(s) | Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum – CCI-779 Safety Reports
A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma
Action Codes | ER |
Study Coordinator(s) | Kim A. Margolin, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D., Lawrence E. Flaherty, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, ECOG |
Revision #5
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Action Codes | ER |
Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Memorandum - Bevacizumab Safety Reports
A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
Action Codes | ER |
Study Coordinator(s) | Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bevacizumab Safety Reports
Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Action Codes | ER |
Study Coordinator(s) | James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - Bevacizumab Safety Reports
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Action Codes | ER |
Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Action Codes | ER |
Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
Action Codes | ER |
Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) or Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX, or XELOX
Action Codes | ER |
Study Coordinator(s) | Philip Gold, M.D., Anthony Shields, M.D.,Ph.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - CC-5013 Safety Report
A Phase II Study of Lenalidomide (Revlimid®) (NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Action Codes | ER |
Study Coordinator(s) | Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma with BAC Features
Action Codes | ER |
Study Coordinator(s) | Howard (Jack) West, M.D., Derick H.M. Lau, M.D.,Ph.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - Bevacizumab Safety Reports
A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
Action Codes | ER |
Study Coordinator(s) | Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - IMC-A12 Safety Reports
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer
Action Codes | ER |
Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #11
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cancer
Action Codes | ER |
Study Coordinator(s) | Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - CC-5013 Safety Report
A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Action Codes | ER |
Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Memorandum - Bevacizumab Safety Reports
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Action Codes | ER |
Study Coordinator(s) | Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY |
Revision #5
A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Action Codes | ER |
Study Coordinator(s) | Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY |
Memorandum - Iodine-131 Labeled Tositumomab Shipments
A Phase II Study of Iodine-131 Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma
Action Codes | NR |
Study Coordinator(s) | Jonathan W. Friedberg, M.D., Oliver W. Press, M.D.,Ph.D., Lisa M. Rimsza, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Revision #4
A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Action Codes | AC, ER |
Study Coordinator(s) | Edgar Ben-Josef, M.D., Mark Zalupski, M.D., Andrew M. Lowy, M.D., Christopher Corless, M.D., Ph.D |
Participants | Members, NCORP, Affiliates, Surgeons, Radiation Oncologists, CTSU |
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