Trial & Business Updates:

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Priority Lists

Activations

S0515Phase II

Activation

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Study Coordinator(s)Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists

Closures

R9811Phase III Intergroup

PERMANENT CLOSURE 6/27/05

Phase III Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin and Radiotherapy in Carcinoma of the Anal Canal
Study Coordinator(s)Charles R. Thomas Jr., M.D., Kevin G. Billingsley, M.D.
ParticipantsNCORP, Members, Surgeons, Radiation Oncologists
Closure Date2005-06-27
R9813Phase IIb

Temporary Closure

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
Study Coordinator(s)Geoffrey R. Barger, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
Closure Date2006-11-01
S0117Phase II

Temporary Closure

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)
Study Coordinator(s)John E. Godwin, M.D., Margaret R. O'Donnell, M.D., David R. Head, M.D., Marilyn L. Slovak, Ph.D., Cheryl L. Willman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2005-10-15

Amendments, Revisions, Memoranda

E1199Phase III Intergroup

Amendment #4

A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paciltaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary Node-Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, Medical Oncologists, Pathologists, NCORP, Surgeons
E1A02Phase II Pilot

Revision #1

Phase II Pilot Study of Rituximab + CHOP in Patients with Newly Diagnosed Waldenstrom's Macroglobulinemia
Study Coordinator(s)Gordan Srkalovic, M.D., Ph.D
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
E2197Phase III Intergroup

Amendment #3

Phase III Study of Adriamycin/Taxotere vs. Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
JPR3Phase III Intergroup

Memorandum

Intergroup (NCIC CTG, CUOG, ECOG, CALGB, SWOG) Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3 - 4, N0, M0 Adenocarcinoma of the Prostate
Action CodesER
Study Coordinator(s)Gregory P. Swanson, M.D.
ParticipantsUCOP, Medical Oncologists, Surgeons, Pathologists, NCORP, Members
JPR7Phase III Intergroup

Memorandum

Intergroup (NCIC, SWOG) Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients with Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
Study Coordinator(s)Celestia S. Higano, M.D.
ParticipantsUCOP, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, NCORP, Members
N9831Phase III Intergroup

Amendment #9

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
Study Coordinator(s)Silvana Martino, D.O.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons
RTOG 0212Phase II-III Intergroup

Memorandum

A Phase II/III Randomized Trial of Two Doses (Phase III-Standard vs. High) and Two High Doe Schedules (Phase II-Once vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer
Study Coordinator(s)Zelanna Goldberg, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists
S0115Phase II

Amendment #4

A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m2) And Autologous Peripheral Blood Stem Cell Supported Transplantation (SCT) For Patients with AL Amyloidosis or High Risk (greater than or equal to Age 70 or Poor Renal Function)Patients With Multiple Myeloma(A BMT Study)
Action CodesER
Study Coordinator(s)Vaishali Sanchorawala, M.D., David C. Seldin, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Limited Institutions: BMT Members
S0124Phase III

Memorandum

Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU
S0202Phase II

Memorandum

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients with Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Study Coordinator(s)Heinz- Josef Lenz, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0205Phase III

Amendment #2

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesIP, AC, FBR
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0205Phase III

Memorandum

A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-C225) Versus Gemcitabine as First-Line Therapy of Patients with Advanced Pancreas Cancer
Action CodesIP, AC, FBR
Study Coordinator(s)Philip A. Philip, M.D.,Ph.D., Cecilia M. Fenoglio-Preiser, M.D., Ralph Wong, M.D., Nancy Vaught, R.N.,O.C.N
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0219Phase II

Memorandum

A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin with Molecular Correlates
Study Coordinator(s)Primo N. Lara, Jr., M.D., Ralph W. deVere White, M.D., Jeffrey P. Gregg, M.D., Paul H. Gumerlock, Ph.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Pathologists, Surgeons
S0303Phase III

Memorandum

A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer
Study Coordinator(s)Charles D. Blanke, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU
S0325Phase IIb

Revision #2

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase.
Action CodesER
Study Coordinator(s)Brian J. Druker, M.D., Marilyn L. Slovak, Ph.D., Jerald P. Radich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG, CALGB, NCIC-CTG
S0342Phase II

Memorandum

Phase II Selection Design Trial of Concurrent Chemotherapy + Cetuximab vs. Chemotherapy Followed by Cetuximab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Karen Kelly, M.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0414Phase II

Memorandum

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial with Molecular Correlates
Study Coordinator(s)Charles R. Thomas Jr., M.D., Charles D. Blanke, M.D., James L. Abbruzzese, M.D., Lisa Hammond, M.D., Vivek Mehta, M.D., Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Radiation Oncologists, Surgeons
S0415Phase II

Memorandum

Cetuximab as a Second Line Therapy in Patients with Metastatic Esophageal Cancer - Phase II
Study Coordinator(s)Philip Gold, M.D.
ParticipantsMembers, NCORP
S9921Phase III Intergroup

Memorandum

Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
Study Coordinator(s)L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D.
ParticipantsMembers, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States

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