Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

Closures

Permanent Closure

Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients with Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged
Action CodesER
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
Closure Date2012-05-01

Amendments, Revisions, Memoranda

S0033Phase III Intergroup

Revision #13

"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 1 of 2 - Clodronate Safety Reports

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Action CodesER, NR
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
S0307Phase III

Memorandum 2 of 2 - Site Reimbursements

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Action CodesER, NR
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
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
S0635Phase II

Memorandum - 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 CodesNR
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 - 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 CodesNR
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 - 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 CodesNR
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

Memorandum - 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
S0777Phase III Intergroup

Memorandum - 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 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 1 of 3 - MRI Diffusion Substudy Closure Effective May 15, 2012

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, NR
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 3 - Expired Kits

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, NR
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 3 of 3 - 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, NR
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 - Revision #7 cover letter clarification

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 - Dose Level Rationale

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 CodesNR
Study Coordinator(s)Daniel O. Persky, M.D., Thomas P. Miller, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0809Phase II

Revision #6

A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Action CodesER
Study Coordinator(s)Edgar Ben-Josef, M.D., Mark Zalupski, M.D., Andrew M. Lowy, M.D., Christopher Corless, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Surgeons, Radiation Oncologists, CTSU

Revision #4

Modified Total Therapy 3 (TT3) for Newly Diagnosed Patients with Multiple Myeloma (MM): A Phase II SWOG Trial for Patients Aged
Action CodesER
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
S0904Phase II

Memorandum - Biologics Holiday Closure

Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel plus Vandetanib in Patients with Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Action CodesNR
Study Coordinator(s)Robert L. Coleman, M.D., Anil K. Sood, M.D.
ParticipantsMembers, Affiliates, NCORP, Medical Oncologists
S0919Phase II

Revision #5

A Phase II Study of Idarubicin and Ara-C in Combination with Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)
Action CodesIP, AC, ER
Study Coordinator(s)Anjali S. Advani, M.D., Edward Copelan, MD, Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S1008Phase II Pilot

Memorandum

Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Action CodesNR
Study Coordinator(s)Heather Greenlee, ND, Ph.D., Dawn Hershman, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page
S1014Phase II

Memorandum - Biologics Holiday Closure

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesNR
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
S1200Phase III

Revision #1

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
Action CodesER
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page
S1201Phase II Pilot

Revision #2

A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
Action CodesER
Study Coordinator(s)Syma Iqbal, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU

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