Trial & Business Updates:

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Priority Lists

Activations

CTSU/E2805Phase III Intergroup

Activation

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Action CodesER
Study Coordinator(s)Christopher G. Wood, M.D.
ParticipantsCTSU
CTSU/E8802Phase II

Activation

Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma with Sarcomatoid Features
Study Coordinator(s)Elisabeth I. Heath, M.D.
ParticipantsCTSU
S0308Phase III
A Phase III Randomized, Multicentered Non-Inferiority Trial Evaluating the Efficacy of Oral Ibandronate versus Intravenous Zoledronate in the Reduction of Skeletal-Related Events in Patients with Metastatic Breast Cancer
Study Coordinator(s)Saul E. Rivkin, M.D., Dawn Hershman, M.D., M.S., Patra Grevstad, R.N., M.N.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists

Closures

Amendments, Revisions, Memoranda

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
S0000Phase III

email memorandum distributed 5/15/06 - translations

Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Study Coordinator(s)Eric A. Klein, M.D., Ian M. Thompson Jr., M.D., Wael A. Sakr, M.D.
ParticipantsInstitutions listed in protocol Appendix 19.5
S0112Phase II

Revision #2

S0112, A Phase II Study Of Daunomycin And Ara-C, Both Given By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older.
Study Coordinator(s)Thomas R. Chauncey, M.D.,Ph.D., Alan F. List, M.D., David R. Head, M.D., Cheryl L. Willman, M.D., Marilyn L. Slovak, Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0115Phase II

Amendment #5

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
S0117Phase II

Revision #7

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
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
S0125Phase II

Revision #2

A Phase II Study of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation in Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (A BMT Study)
Study Coordinator(s)Peter A. McSweeney, M.D., Thomas R. Chauncey, M.D.,Ph.D., Scott I. Bearman, M.D., Anwar N. Mohamed, M.D., Cheryl L. Willman, M.D.
ParticipantsLimited Institutions: Allogeneic BMT Members
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 CodesER
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
S0307Phase III

Memorandum

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
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
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
S0346Phase II

Memorandum

Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma
Study Coordinator(s)Ernest C. Borden, M.D., Rashmi Chugh, M.D., George Demetri, M.D., Margaret von Mehren, M.D., Vivien Bramwell, M.D.,Ph.D., Karen H. Albritton, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Intergroup Coalition Against Sarcomas Members, CTSU
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
S0429Phase I Pilot

Memorandum

A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Action CodesER
Study Coordinator(s)Yuhchyau Chen, M.D., Ph.D, Kishan J. Pandya, M.D., Karen Kelly, M.D., Derick H.M. Lau, M.D.,Ph.D., Laurie E. Gaspar, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Pathologists
S0431Phase II

Memorandum

Phase II Study of Trastuzumab (NSC-688097) in Advanced High Grade Salivary Gland Carcinoma
Study Coordinator(s)Madeleine Kane, M.D., Ph.D, Adel K. El-Naggar, M.D., Ph.D, Stephen K. Williamson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, ECOG
S0433Phase II

Revision #2

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study
Study Coordinator(s)Jonathan W. Friedberg, M.D., Richard I. Fisher, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0434Phase II

Revision #1

A Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients with Relapsing or Resistant Multiple Myeloma
Action CodesER
Study Coordinator(s)Mohamad A. Hussein, M.D., Gordan Srkalovic, M.D., Ph.D
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists
S0505Phase II

Revision #1

Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Study Coordinator(s)Margaret von Mehren, M.D., John Goldblum, M.D., George Demetri, M.D., Vivien Bramwell, M.D.,Ph.D.
ParticipantsIntergroup Coalition Against Sarcomas Members, Members, NCORP, Affiliates, Medical Oncologists, CTSU
S0508Phase II

Revision #3

Phase II Trial of Combination Thalidomide plus Temozolomide in Patients with Metastatic Melanoma
Study Coordinator(s)Joseph I. Clark, M.D., Laura F. Hutchins, M.D., Jeffrey A. Sosman, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0509Phase II

Memorandum

A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
Action CodesER
Study Coordinator(s)Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
S0515Phase II

Amendment #1

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
SWOG-9400Phase II

Revision #10

Treatment of Adult Lymphoblastic Leukemia: A Phase II Trial of An Induction Regimen Including PEG-L-Asparaginase in Previously Untreated Patients, Followed By Allogeneic Bone Marrow Transplantation or Further Chemotherapy In First Complete Remission
Study Coordinator(s)Stephen J. Forman, M.D., Chatchada Karanes, M.D., Nelson J.A. Chao, M.D.

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