Priority Lists
Protocol Posting of
Activations
Closures
Temporary Closure effective 12/16/11
Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic Smoldering Multiple Myeloma
| Action Codes | ER |
| Study Coordinator(s) | Madhav V. Dhodapkar, M.D., John Shaughnessy, Ph.D. |
| Participants | CTSU |
| Closure Date | 2017-07-14 |
Permanent Closure Notice
"Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High -Risk Node Negative Breast Cancer"
| Action Codes | ER |
| Study Coordinator(s) | G. Thomas Budd, M.D., Halle C.F. Moore, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
| Closure Date | 2012-01-15 |
Permanent Closure
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 |
| Closure Date | 2012-02-01 |
Amendments, Revisions, Memoranda
Memorandum - Permanent Study Closure
Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate
| Action Codes | ER |
| Study Coordinator(s) | Gregory P. Swanson, M.D. |
| Participants | UCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members |
Revision #9
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
| Action Codes | ER |
| Study Coordinator(s) | Stephen H. Petersdorf, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU |
Memorandum - Clodronate Safety Report
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 #16
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 - 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
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 |
Revision #10
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 - 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 #8
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 - 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 - 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 #10
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 | 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 |
Revision #9
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 | 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 |
Memorandum - MK-2206 Safety Report
A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
| Action Codes | ER |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D. |
| Participants | Medical Oncologists, Members, NCORP, Affiliates |
Memorandum - Investigator Training
A Phase II Prospective Study of Epidermal Growth Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-induced Skin Toxicities
| Action Codes | NR |
| Study Coordinator(s) | Siu-Fun Wong, Pharm.D., Carol M. Moinpour, Ph.D., James L. Wade, III, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
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