Priority Lists
Protocol Posting of
Activations
Activation
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D., Jonathan W. Friedberg, M.D., Richard K.J. Brown, M.D., Lisa M. Rimsza, M.D., James Cook, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CALGB, ECOG |
Activation
A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
| Study Coordinator(s) | Christopher D. Lao, M.D., M.P., John Fruehauf, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Closures
Permanent Closure
Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin’s Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D. |
| Participants | Limited Institutions: BMT Members |
| Closure Date | 2009-07-17 |
Amendments, Revisions, Memoranda
Memorandum
Selenium and Vitamin E Cancer Prevention Trial (SELECT)
| Action Codes | NR |
| Study Coordinator(s) | Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D. |
| Participants | Institutions listed in protocol Appendix 19.5 |
Revision #5
S0000D, "A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT, Phase III Ancillary to S0000-SELECT
| Action Codes | FBR, ER |
| Study Coordinator(s) | M. Peter Lance, M.D., David S. Alberts, M.D., Achyut Battacharyya, M.D., Sylvan Green, M.D., Maria Elena Martinez, Ph.D. |
| Participants | Participating Study Centers listed in Appendix Section 19.1 |
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 - Dasatinib Safety Report
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
| Action Codes | ER |
| Study Coordinator(s) | Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG |
Memorandum
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
| Action Codes | AC, ER |
| Study Coordinator(s) | David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States |
Revision #3
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
| Action Codes | AC, ER |
| Study Coordinator(s) | David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States |
Revision #4
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
| Action Codes | AC, ER |
| Study Coordinator(s) | David I. Quinn, M.D., Ph.D, Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D., Mark G. Garzotto, M.D., Carol M. Moinpour, Ph.D., Philip C. Mack, Ph.D., Karen M. Baranowski, N.P. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons, CTSU Institutions in the United States |
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 |
Memorandum
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 |
Revision #3
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 - AZD2171 Safety Reports
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum - Bevacizumab Safety Reports
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Action Codes | ER |
| Study Coordinator(s) | Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
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 - PXD101 Safety Report
Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
| Action Codes | ER |
| Study Coordinator(s) | Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
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
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 - Dasatinib Safety Report
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
| Action Codes | ER |
| Study Coordinator(s) | Anne F. Schott, M.D., Catherine Van Poznak, 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 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 |
Revision #3
A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
| Action Codes | ER |
| Study Coordinator(s) | Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Members, Medical Oncologists, Pathologists |
Memorandum - Child-Pugh Classification Score Worksheet
Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction."
| Action Codes | NR |
| Study Coordinator(s) | John Sarantopolous, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - Bevacizumab Safety Reports
A Phase I and A Randomized Phase II Study of Maximal Angiogenic Blockade in Advanced Renal Carcinoma: Bevacizumab (NSC-704865) with or without MEDI-522 (NSC-719850)
| Action Codes | ER |
| Study Coordinator(s) | Christopher W. Ryan, M.D., Theresa M. Koppie, M.D., Philip C. Mack, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
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 #3
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 | AC, 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 - AVE0005 Safety Reports
A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
| Action Codes | ER |
| Study Coordinator(s) | Jeffrey W. Allen, M.D., Karen Kelly, M.D., Philip C. Mack, Ph.D., Shirish M. Gadgeel, M.D. |
| Participants | Members, NCORP, Affiliates, 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