Trial & Business Updates:

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Priority Lists

Activations

Closures

CTSU/PR11Phase III Intergroup

Permanent Closure effective 5/15/11

A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)
Action CodesER
Study Coordinator(s)Ian M. Thompson Jr., M.D.
ParticipantsCTSU
Closure Date2011-05-15
S0230Phase III

Permanent Closure - Effective 6/1/11

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
Action CodesER
Study Coordinator(s)Halle C.F. Moore, M.D., Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CALGB, ECOG, IBCSG
S0703Phase II

Partial Permanent Closure

A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
Action CodesER
Study Coordinator(s)Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Members, Medical Oncologists, Pathologists
S0905Phase II

Temporary Closure effective May 4, 2011

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 CodesER
Study Coordinator(s)Anne Tsao, M.D., Nicholas J. Vogelzang, M.D., Ignacio I. Wistuba, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
Closure Date2016-02-15

Amendments, Revisions, Memoranda

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
S0438Phase II Intergroup

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 CodesER
Study Coordinator(s)Kim A. Margolin, M.D., Vernon K. Sondak, M.D., Jeffrey A. Sosman, M.D., Lawrence E. Flaherty, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, ECOG
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
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
S0533Pilot

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 CodesER
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0535Phase II

Memorandum - Biologics Holiday Closure

A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
Action CodesNR
Study Coordinator(s)Jeffrey E. Lancet, M.D., Rami Komrokji, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsNCORP, Affiliates, Medical Oncologists, Members, Pathologists, CTSU
S0536Phase II

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 CodesER
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
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 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 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
S0635Phase II

Memorandum 1 of 2 - Biologics Holiday Closure

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
S0635Phase II

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 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 1 of 2 - Biologics Holiday Closure

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
S0636Phase II

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 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
S0703Phase II

Memorandum 1 of 2 - Azacitidine Safety Report

A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
Action CodesER
Study Coordinator(s)Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Members, Medical Oncologists, Pathologists
S0703Phase II

Memorandum 2 of 2 - Biologics Holiday Closure

A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia
Action CodesER
Study Coordinator(s)Sucha Nand, M.D., John E. Godwin, M.D., Cheryl L. Willman, M.D., Thomas H. Norwood, M.D., Frederick R. Appelbaum, M.D.
ParticipantsAffiliates, NCORP, Members, Medical Oncologists, Pathologists
S0709Phase II

Biologics Holiday Closure

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 CodesNR
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.
ParticipantsMembers, NCORP, Medical Oncologists, Affiliates
S0722Phase II

Memorandum - RAD001 5 mg Shortage

A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM)
Action CodesER
Study Coordinator(s)Sai-Hong Ignatius Ou, M.D., Ph.D, Linda L. Garland, M.D., Philip C. Mack, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates
S0727Phase I-II

Memorandum - IMC-A12 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 CodesER
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0777Phase III Intergroup

Memorandum - 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 CodesAC, 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 #11

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 CodesAC, 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 1 of 2 - Biologics Holiday Closure

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
S0800Phase II

Memorandum 2 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 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
S0819Phase III Intergroup

Memorandum - Update to Drs. Herbst and Semrad contact info

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 CodesNR
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.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States

Memorandum - Revision #1 Cover Memo Error

Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients with Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged
Action CodesNR
Study Coordinator(s)Muneer H. Abidi, M.D., Bart Barlogie, M.D.,Ph.D., Frits van Rhee, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0925Phase II

Memorandum - IMC-A12 Safety Report

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 CodesER
Study Coordinator(s)Evan Y. Yu, M.D., Celestia S. Higano, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
S0933Phase II

Revision #2

Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
Action CodesER
Study Coordinator(s)Kim A. Margolin, M.D., Thomas Gajewski, M.D., Ph.D
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, Affiliates
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
S1005Phase II

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 CodesER
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates

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