Trial & Business Updates:

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Priority Lists

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Closures

Amendments, Revisions, Memoranda

JMA17Phase III Intergroup

Memorandum - Unblinding Procedures

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.
S0535Phase II

Memorandum - Eligibility Affirmation

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
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

Funding Memorandum

"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 CodesNR
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
ParticipantsMembers, NCORP, Affiliates, CTSU

Memorandum - Eligibility Affirmation

"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 CodesNR
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
ParticipantsMembers, NCORP, Affiliates, CTSU
S0709Phase II

Memorandum - Eligibility Affirmation

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
S0713Phase II

Memorandum - Eligibility Affirmation

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 - CC-5013 Safety Reports

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
S0805Phase II

Memorandum - Eligibility Affirmation

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 CodesNR
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.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, BMT CTN
S0806Phase I-II

Memorandum - Eligibility Affirmation

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
S0812Phase IIb

Memorandum - Eligibility Affirmation

“Phase IIB Randomized Controlled Biomarker Modulation Study of Vitamin D in Premenopausal Women at High Risk for Breast Cancer."
Action CodesNR
Study Coordinator(s)Katherine Crew, M.D., M.S.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S0819Phase III Intergroup

Memorandum - Eligibility Affirmation

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
S0905Phase II

Memorandum - Eligibility Affirmation

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 CodesNR
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 Safety Reports

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 CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Steven E. Coutre, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0919Phase II

Memorandum - Eligibility Affirmation

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
S0927Phase III

Memorandum - Eligibility Affirmation

Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain in Women with Early Stage Breast Cancer, Phase III
Action CodesNR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Katherine Crew, M.D., M.S., Carol M. Moinpour, Ph.D.
ParticipantsMembers, NCORP, Affiliates, Pathologists
S0931Phase III

Memorandum - Eligibility Affirmation

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
Action CodesNR
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
S1001Phase II

Memorandum - Eligibility Affirmation

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
Action CodesNR
Study Coordinator(s)Daniel O. Persky, M.D.
ParticipantsNCORP, Affiliates, CTSU, Members
S1005Phase II

Memorandum - Eligibility Affirmation

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Action CodesNR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates
S1007Phase III Intergroup

Memorandum - Eligibility Affirmation

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Action CodesNR
Study Coordinator(s)Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1008Phase II Pilot

Memorandum - Eligibility Affirmation

Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Action CodesER, NR
Study Coordinator(s)Heather Greenlee, ND, Ph.D., Dawn Hershman, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page
S1008Phase II Pilot

Revision #2

Feasibility Study of a Physical Activity and Dietary Change Weight Loss Intervention In Breast and Colorectal Cancer Survivors, Phase II
Action CodesER, NR
Study Coordinator(s)Heather Greenlee, ND, Ph.D., Dawn Hershman, M.D., M.S.
ParticipantsLimited: Institutions Listed on the Title Page
S1011Phase III Intergroup

Memorandum - Eligibility Affirmation

A Phase III Surgical Trial to Evaluate The Benefit Of A Standard Versus An Extended Pelvic Lymphadenectomy Performed At Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
Action CodesNR
Study Coordinator(s)Seth P. Lerner, M.D., Theresa M. Koppie, M.D., Ajjai S. Alva, M.D., Robert S. Svatek, M.D., Sumanta K. Pal, M.D., Francisco G. LaRosa, M.D., Rick Bangs
ParticipantsLimited: Credentialed Surgeons Listed on S1011 Abstract Page
S1013Phase II

Memorandum - Eligibility Affirmation

A Phase II Prospective Study of Epidermal Growth Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-induced Skin Toxicities
Action CodesNR
Study Coordinator(s)Siu-Fun Wong, Pharm.D., Carol M. Moinpour, Ph.D., James L. Wade, III, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1013Phase II

Revision #2

A Phase II Prospective Study of Epidermal Growth Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-induced Skin Toxicities
Action CodesNR
Study Coordinator(s)Siu-Fun Wong, Pharm.D., Carol M. Moinpour, Ph.D., James L. Wade, III, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1014Phase II

Memorandum - Eligibility Affirmation

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

Memorandum - Eligibility Affirmation

Randomized Trial Of A Text-Messaging Intervention To Reduce Early Discontinuation Of Adjuvant Aromatase Inhibitor Therapy In Women With Early Stage Breast Cancer
Action CodesNR
Study Coordinator(s)Alfred Neugut, M.D., Dawn Hershman, M.D., M.S., Lisa Sparks, Ph.D,
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S1106Phase II Intergroup

Memorandum 1 of 2 - Eligibility Affirmation

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
Action CodesNR
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
S1106Phase II Intergroup

Memorandum 2 of 2 - Sequenta Holiday Closure

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
Action CodesNR
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
S1107Phase II

Memorandum - Eligibility Affirmation

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
Action CodesNR
Study Coordinator(s)Przemyslaw W. Twardowski, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU
S1108Phase II

Memorandum - Eligibility Affirmation

Phase II Trial of the Aurora Kinase A Inhibitor, MLN8237, in Peripheral T-Cell Non-Hodgkin Lymphoma
Action CodesNR
Study Coordinator(s)Paul M. Barr, M.D., Jonathan W. Friedberg, M.D., Daruka Mahadevan, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU
S1115Phase II

Memorandum - Eligibility Affirmation

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) vs. mFOLFOX in Patients with Metastatic Pancreatic Cancer after Prior Chemotherapy
Action CodesNR
Study Coordinator(s)Vincent Chung, M.D., Philip A. Philip, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1117Phase II Intergroup

Memorandum 1 of 2 - CC-5013 Safety Reports

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 CodesER, NR
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1117Phase II Intergroup

Memorandum 2 of 2 - Eligibility Affirmation

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 CodesER, NR
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1200Phase III

Memorandum - Eligibility Affirmation

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

Memorandum - Eligibility Affirmation

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 CodesNR
Study Coordinator(s)Syma Iqbal, M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, CTSU
S1206 (8811)Phase II

Memorandum - Eligibility Affirmation

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added To Chemoradiotherapy with Carboplatin and Paclitaxel for Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)
Action CodesNR
Study Coordinator(s)Athanassios Argiris, M.D., Mihaela Cristea, M.D., Allen M. Chen, M.D.
ParticipantsSWOG
S1211Phase I-II

Memorandum - Eligibility Affirmation

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesNR
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
  • 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