Priority Lists
Protocol Posting of
Activations
Activation effective August 1, 2010
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma
Action Codes | ER |
Study Coordinator(s) | Andrei R. Shustov, M.D. |
Participants | CTSU |
Re-Activation effective 7/29/10
Prevention of Cataract and Age-Related Macular Degeneration with Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
Action Codes | ER |
Study Coordinator(s) | William Christen, Sc.D., Robert Glynn, Sc.D., J. Michael Gaziano, M.D. |
Participants | Institutions listed in protocol Appendix 19.5 |
Closures
Permanent Closure effective July 30, 2010
Cyclophosphamide and Doxorubicin (CA) (4 vs. 6 Cycles) Versus Paclitaxel (12 Weeks vs 18 Weeks) as Adjuvant Therapy for Women With Node-Negative Breast Cancer: A 2X2 Factorial Phase III Randomized Study
Action Codes | ER |
Study Coordinator(s) | Silvana Martino, D.O. |
Participants | CTSU |
Closure Date | 2010-07-30 |
Permanent Closure effective July 14, 2010
Endocrine Therapy with or without Inhibition of EGF and GER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant with or without Lapatinib (GW572016) for Postmenopausal Women with Estrogen-Receptor Positive Advanced Breast Cancer
Action Codes | ER |
Study Coordinator(s) | Helen K. Chew, M.D. |
Participants | CTSU |
Closure Date | 2010-07-14 |
Amendments, Revisions, Memoranda
Memorandum - Forms Packet
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 |
Revision #14
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 - 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 - 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 - CellSave Tube Expiration
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 | NR |
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 Report
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 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 - Post-Consolidation Treatment Update
A Randomized Trial of Maintenance versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
Action Codes | ER |
Study Coordinator(s) | Steven E. Coutre, M.D., Diane L. Persons, M.D., Cheryl L. Willman, M.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Memorandum - RAD001 Expiration Notice
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
Action Codes | NR |
Study Coordinator(s) | Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D. |
Participants | Limited: Institutions Listed on the Title Page |
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 |
Revision #9
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 |
Revision #7
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 - CellSave Tube Expiration
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 - Revision #5 Clarification
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 #5
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 | ER |
Study Coordinator(s) | John Sarantopolous, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum - RAD001 Expiration Notice
A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)
Action Codes | NR |
Study Coordinator(s) | Sai-Hong Ignatius Ou, M.D., Ph.D, Linda L. Garland, M.D., Philip C. Mack, Ph.D. |
Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates |
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 |
Memorandum - Bortezomib 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 |
Memorandum - AVE0005 Safety Report
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 |
Revision #3
Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL)
Action Codes | AC, FBR, ER |
Study Coordinator(s) | Farhad Ravandi, M.D., Susan O'Brien, M.D., Stephen J. Forman, M.D., Chul S. Ha, M.D., Jeffrey Y.C. Wong, M.D., Jerald P. Radich, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, BMT CTN |
Memorandum - AZD2171 Safety Report
A Phase I / Randomized Phase II Study of Cediranib (NSC #732208) Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma
Action Codes | ER |
Study Coordinator(s) | Anne Tsao, M.D., Nicholas J. Vogelzang, M.D., Ignacio I. Wistuba, 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