Trial & Business Updates:

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Priority Lists

Activations

S1316Phase III

Activation - Effective 3/9/15

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action CodesFBR
Study Coordinator(s)Robert S. Krouse, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Closures

Amendments, Revisions, Memoranda

CTSU/NSABP B-47Phase III Intergroup

Permanent Closure - Effective 2/10/15

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of TC or Four Cycles of AC Followed by Four Cycles of Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Normal Invasive Breast Cancer
Action CodesER
Study Coordinator(s)Kathy Albain, M.D.
ParticipantsCTSU
S0033Phase III Intergroup

Memorandum - IND Withdrawal

"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 CodesNR
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S0211Phase II

Memorandum - IND Withdrawal

A Phase II Trial of STI571 for the Treatment of Platinum and Taxane Refractory Stage III and IV Epithelial Ovarian Cancer and Primary Peritoneal Cancer
Action CodesNR
Study Coordinator(s)Andy Jang, M.D., Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists
S0331Phase II

Memorandum - IND Withdrawal

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Action CodesNR
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
S0338Phase II

Memorandum - IND Withdrawal

Phase II Trial of Imatinib Mesylate (Gleevec) (NSC-716051) In Combination With Capecitabine (Xeloda) (NSC-712807) In Metastatic Breast Cancer
Action CodesNR
Study Coordinator(s)Helen K. Chew, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0345Phase II

Memorandum - IND Withdrawal

A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
Action CodesNR
Study Coordinator(s)Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0502Phase III

Memorandum - Bevacizumab Safety Report

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 Report

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

Memorandum - Everolimus Safety Reports

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
S0533Pilot

Memorandum - Bevacizumab Safety Report

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
S0635Phase II

Memorandum - Bevacizumab 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 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 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 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
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 CodesER
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 Report

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
S0819Phase III Intergroup

Memorandum - Bevacizumab Safety Report

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 CodesER
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
S0919Phase II

Revision #8

A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0931Phase III

Memorandum - Everolimus Safety Reports

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
Action CodesER
Study Coordinator(s)Christopher W. Ryan, M.D., Elisabeth I. Heath, M.D., Primo N. Lara, Jr., M.D., Ganesh S. Palapattu, M.D., Philip C. Mack, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1117Phase II Intergroup

Memorandum - CC-5013 Safety Report

A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Action CodesNR
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1200Phase III

Memorandum - Master Forms Set Update

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
Action CodesNR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page

S1204 Funding Memo

A Sero-Epidemiologic Survey and Cost-effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
Study Coordinator(s)Scott Ramsey, M.D.
ParticipantsSWOG, NCORP, Affiliates, Medical Oncologists
S1207Phase III

Memorandum - Everolimus Safety Reports

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesNR
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1221Phase I-II

Memorandum 1 of 2 - Dabrafenib Mesylate Safety Report

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER, NR
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1221Phase I-II

Memorandum 2 of 2 - Trametinib Safety Report

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER, NR
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1222Phase III

Memorandum - Everolimus Safety Reports

Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial In Postmenopausal Patients With Hormone-Receptor Positive Stage IV Breast Cancer.
Action CodesER
Study Coordinator(s)George Somlo, M.D., Halle C.F. Moore, M.D., Daniel F. Hayes, M.D.
ParticipantsNCORP, Affiliates, Members, Medical Oncologists, Surgeons
S1310Phase II

Memorandum - Trametinib Safety Report

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Action CodesER
Study Coordinator(s)Richard D. Kim, M.D., Anthony El-Khoueiry, M.D.
ParticipantsMembers, NCORP, Affiliates
S1320Phase II

Memorandum 1 of 2 - Dabrafenib Mesylate Safety Report

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesER
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1320Phase II

Memorandum 2 of 2 - Trametinib Safety Report

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesER
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1400Phase II-III Intergroup

Memorandum - MEDI4736 Safety Report (for S1400A)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER
Study Coordinator(s)Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG

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