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Priority Lists

Activations

S1106Phase II Intergroup

Activation - 10/1/11

A Randomized Phase II Trial of R-HCVAD-MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients
Study Coordinator(s)Steven Bernstein, M.D., Robert Chen, M.D., Stephen J. Forman, M.D., Louis S. Constine, M.D., Lisa M. Rimsza, M.D.
ParticipantsCTSU

Closures

Permanent Closure effective October 15, 2011 at 5:00 pm EST

Phase III Randomized Study of Induction Therapy Comprising Daunorubicin Hydrochloride and Cytarabine With or Without Midostaurin Followed by Consolidation Therapy Comprising High-Dose Cytarabine and Midostaurin Followed by Continuation Therapy Comprising Midostaurin Alone in Patients With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia
Study Coordinator(s)Bruno Medeiros, M.D.
ParticipantsCTSU
Closure Date2011-10-15

Amendments, Revisions, Memoranda

JMA17Phase III Intergroup

Memorandum - Investigator Letter

A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Action CodesNR
Study Coordinator(s)Silvana Martino, D.O.
S0033Phase III Intergroup

Memorandum - Imatinib Safety Report

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
Action CodesER
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S0307Phase III

Memorandum - Clodronate Safety Reports

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Action CodesER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU
S0500Phase III

Memorandum - Cell Save 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 CodesNR
Study Coordinator(s)Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States
S0502Phase III

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 CodesER
Study Coordinator(s)Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0502Phase III

Revision #5

A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors
Action CodesER
Study Coordinator(s)Charles D. Blanke, M.D., Michael C. Heinrich, M.D., Christopher Corless, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0512Phase II

Revision #4

Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) in Combination with Carboplatin and Paclitaxel in Patients with Metastatic Uveal Melanoma
Action CodesER
Study Coordinator(s)Ana Aparicio, M.D., Jeffrey S. Weber, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0518Phase III

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 CodesER
Study Coordinator(s)James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0528Phase I

Revision #7

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 CodesER
Study Coordinator(s)Shirish M. Gadgeel, M.D., Timothy W. Synold, Pharm. D., Patricia LoRusso, D.O., Jennifer Carew, Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0600Phase III

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 CodesER
Study Coordinator(s)Philip Gold, M.D., Anthony Shields, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S0605Phase II

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 CodesER
Study Coordinator(s)Mikkael A. Sekeres, M.D., M.S., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0622Phase II

Revision #9

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Action CodesER
Study Coordinator(s)Anne F. Schott, M.D., Catherine Van Poznak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0635Phase II

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 CodesER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0636Phase II

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 CodesER
Study Coordinator(s)Howard (Jack) West, M.D., Fred R. Hirsch, M.D.,Ph.D., Antoinette J. Wozniak, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0713Phase II

Memo - Drug Ordering Information

A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-operative Therapy of Rectal Cancer
Action CodesNR
Study Coordinator(s)Cynthia G. Leichman, M.D., Stephen R. Smalley, M.D., Kevin G. Billingsley, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons
S0777Phase III Intergroup

Memorandum 1 of 2 - Lenalidomide 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 CodesIP, AC, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0777Phase III Intergroup

Memorandum 2 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 CodesIP, AC, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0777Phase III Intergroup

Revision #13

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 CodesIP, AC, ER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0800Phase II

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 CodesER
Study Coordinator(s)Zeina Nahleh, M.D., Daniel F. Hayes, M.D., Anne F. Schott, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, US INSTITUTIONS ONLY
S0802Phase II

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 CodesER
Study Coordinator(s)Jeffrey W. Allen, M.D., Karen Kelly, M.D., Philip C. Mack, Ph.D., Shirish M. Gadgeel, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0806Phase I-II

Memorandum - SAHA Safety Report

A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination with Rituximab-CHOP in Patients with Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)
Action CodesER
Study Coordinator(s)Daniel O. Persky, M.D., Thomas P. Miller, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0826Phase II

Memorandum - SCH727965 Safety Report

A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma
Action CodesER
Study Coordinator(s)Christopher D. Lao, M.D., M.P., John Fruehauf, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0905Phase II

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 CodesFBR, ER
Study Coordinator(s)Anne Tsao, M.D., Nicholas J. Vogelzang, M.D., Ignacio I. Wistuba, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0910Phase II

Memorandum - Epratuzumab Lot 1003164 Expiration Extension

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 CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Steven E. Coutre, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0941Phase II

Memorandum - 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 CodesER
Study Coordinator(s)Anthony El-Khoueiry, M.D.
ParticipantsMembers, 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