Priority Lists
Protocol Posting of
Activations
Memorandum – Distribution for IRB Review Only
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
Study Coordinator(s) | Jason A. Zell, D.O. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Closures
Amendments, Revisions, Memoranda
Memorandum - Lenalidomide Action Letter
"A Genetic Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia."
Action Codes | ER |
Study Coordinator(s) | John E. Godwin, M.D., Frederick R. Appelbaum, M.D. |
Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Memorandum - Lenalidomide Action Letter
A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women with Node Positive Stage II/IIIA Breast Cancer
Study Coordinator(s) | John E. Godwin, M.D., Frederick R. Appelbaum, M.D. |
Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Memorandum - Lenalidomide Action Letter
Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin’s Lymphoma Beyond First Complete Response
Study Coordinator(s) | John E. Godwin, M.D., Frederick R. Appelbaum, M.D. |
Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
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 |
Revision #14
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 | IP, AC, 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 - BAY 43-9006 Safety Report
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 - Expiring CellSave Tubes
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 - 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 | AC, 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 |
Revision #5
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 | AC, 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 |
Revision #7
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 - 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 #10
A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
Action Codes | ER |
Study Coordinator(s) | Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
Participants | NCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU |
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 Reports
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 - Expiring CellSave Tubes
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action Codes | IP, AC, ER |
Study Coordinator(s) | Anne F. Schott, M.D., Catherine Van Poznak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #8
Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action Codes | IP, AC, ER |
Study Coordinator(s) | Anne F. Schott, M.D., Catherine Van Poznak, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 1 of 2 - OSI-774 Safety Report
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 2 of 2 - 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 |
Revision #9
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 1 of 2 - OSI-774 Safety Report
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 2 of 2 - 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 #10
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 #7
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 | IP, AC, ER |
Study Coordinator(s) | John Sarantopolous, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum 1 of 2 - 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 2 of 2 - OSI-774 Safety Report
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 1 of 2 - 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 2 of 2 - CC-5013 Safety Reports
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 |
Revision #10
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 - Dear Doctor Letter
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 | IP, AC, 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 1 of 2 - 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 | IP, AC, 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 2 of 2 - Avastin Findings
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 | IP, AC, 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 #8
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 | IP, AC, 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 #8
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 | IP, AC, 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 #6
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 | IP, AC, 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 - IMC-A12 Safety Reports
A Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-Sensitive Metastatic Prostate Cancer
Action Codes | ER |
Study Coordinator(s) | Evan Y. Yu, M.D., Celestia S. Higano, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons |
Revision #1
Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
Action Codes | IP, AC, ER |
Study Coordinator(s) | Kim A. Margolin, M.D., Thomas Gajewski, M.D., Ph.D |
Participants | Members, Medical Oncologists, Pathologists, NCORP, Affiliates |
Memorandum 1 of 2 - BAY 43-9006 Safety Report
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma
Action Codes | ER |
Study Coordinator(s) | Anthony El-Khoueiry, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum 2 of 2 - OSI-774 Safety Report
Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma
Action Codes | ER |
Study Coordinator(s) | Anthony El-Khoueiry, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum - 28 Day Waiting Period
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action Codes | NR |
Study Coordinator(s) | Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D. |
Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
- 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