Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure Effective 12/10/2010 5:00 P.M. EST
The BeST Trial: A Randomized Phase II study of VEGF, RAF kinase and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma
| Action Codes | ER |
| Study Coordinator(s) | Kim A. Margolin, M.D. |
| Participants | CTSU |
| Closure Date | 2010-12-10 |
Permanent Closure Effective 12/15/10
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 |
| Closure Date | 2010-12-15 |
Permanent Closure Effective 12/15/10
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 | ER |
| 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 |
| Closure Date | 2010-12-15 |
Temporary Closure
A Phase II Trial of the Anti-CCR2 Antibody MLN1202 in Patients with Bone Metastases
| Action Codes | ER |
| Study Coordinator(s) | Kenneth J. Pienta, M.D., John Sarantopolous, M.D. |
| Participants | Limited: Institutions Listed on SWOG Activation Memorandum |
| Closure Date | 2011-03-15 |
Amendments, Revisions, Memoranda
Memorandum - Pathology Lab Holiday Closure
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Memorandum - Pathology Lab Holiday Closure
"A Genetic Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia."
| Action Codes | NR |
| Study Coordinator(s) | John E. Godwin, M.D., Frederick R. Appelbaum, M.D. |
| Participants | Affiliates, NCORP, Medical Oncologists, Members, Pathologists |
Memorandum - Pathology Lab Holiday Closure
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 - Pathology Lab Holiday Closure
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 - Doxorubicin Shortage
"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 |
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 #4
A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Edward M. Messing, M.D., Deepak M. Sahasrabudhe, M.D., Theresa M. Koppie, M.D., David P. Wood Jr., M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Pathologists |
Memorandum - CTEP IND Withdrawal for SB-715992
A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
| Action Codes | ER |
| Study Coordinator(s) | Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Timothy W. Synold, Pharm. D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Memorandum - Holiday Shipping
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 - 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: Revised reimbursement form
"A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment"
| Action Codes | NR |
| Study Coordinator(s) | Catherine Van Poznak, M.D., Julie R. Gralow, M.D., Lisa Hansen, R.N., M.S., Robert A. Bagramian, DDS, Mark Schubert, DDS, MSD |
| Participants | Members, NCORP, Affiliates, CTSU |
Revision #5
A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics
| Action Codes | AC, ER |
| Study Coordinator(s) | Primo N. Lara, Jr., M.D., Paul J. Hesketh, M.D., Philip C. Mack, Ph.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Affiliates |
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 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 1 of 2 - Doxorubicin Shortage
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, NR |
| 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: Timeframe for beginning treatment
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, NR |
| 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 - Doxorubicin Shortage
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 - Doxorubicin Shortage
A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging
| Action Codes | ER |
| 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 |
Revision #7
A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
| Action Codes | ER |
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D. |
| Participants | Members, NCORP, Affiliates, CTSU Institutions in the United States |
Memorandum - SCH727965 Safety Report
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 |
Memorandum - Genzyme Holiday Closure
A Phase II Study of Epratuzumab in Combination with Cytarabine and Clofarabine for Patients with Relapsed or Refractory Precursor B-cell Acute Lymphoblastic Leukemia
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Steven E. Coutre, 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