Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

Activation

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Action CodesER
Study Coordinator(s)Daniel F. Hayes, M.D.
ParticipantsCTSU

Activation

The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study To NCIC CTG MA.27
Action CodesER
Study Coordinator(s)G. Thomas Budd, M.D.
ParticipantsCTSU
CTSU/NCIC-CTG MA.27BAncillary Intergroup

Activation

The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer
Action CodesER
Study Coordinator(s)Dawn Hershman, M.D., M.S.
ParticipantsCTSU
R9813Phase IIb

Re-Activation

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
S0425Phase II Pilot

Activation

Neoadjuvant Chemoradiation Therapy with Oxaliplatin and Capecitabine for Patients with Surgically Resectable Gastric Cancer: A Pilot Phase II Trial with Molecular Correlates
Study Coordinator(s)Syed Ahmad, M.D., Lawrence P. Leichman, M.D., Lisa Kachnic, M.D., Scott A. Hundahl, M.D., Cecilia M. Fenoglio-Preiser, M.D., Charles D. Blanke, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, Radiation Oncologists, Surgeons
S0618Phase II

Activation

Phase II Evaluation of E7389 (NSC-707389) in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Coordinator(s)Susanne M. Arnold, M.D.
ParticipantsMembers, NCORP, Affiliates

Closures

S0349Phase II

Permanent closure & Memorandum

Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonucleotide (BCL-2 Antisense - NSC-683428) Therapy for Young Patients (< Age 60) with Advanced Stage Diffuse Large B-cell NHL of Low and Low-Intermediate IPI Risk
Study Coordinator(s)Steven Bernstein, M.D., Richard I. Fisher, M.D., Thomas M. Grogan, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
Closure Date2006-05-15
S0413Phase II

Permanent Closure effective 5/15/06

Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients with Advanced or Metastatic Gastric Cancer
Study Coordinator(s)Heinz- Josef Lenz, M.D., Cecilia M. Fenoglio-Preiser, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
Closure Date2006-05-15
S0418Phase II

Permanent Closure

A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Taxane-Resistant Androgen-Independent Metastatic Prostate Cancer
Study Coordinator(s)Tomasz M. Beer, M.D., Christopher W. Ryan, M.D., Timothy W. Synold, Pharm. D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons
Closure Date2006-05-01
S0435Phase II

Partial Temporary Closure effective 5/15/06

A Phase II Trial of BAY 43-9006 (NSC-724772) in Patients with Platinum-Treated Extensive Stage Small Cell Lung Cancer
Study Coordinator(s)Barbara J. Gitlitz, M.D., Bonnie S. Glisson, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists
Closure Date2007-02-15

Amendments, Revisions, Memoranda

E1A02Phase II Pilot

Revision #2

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
S0033Phase III Intergroup

Memorandum

"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)"
Study Coordinator(s)George Demetri, M.D., Christopher Fletcher, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG
S0200Phase III

Memorandum

A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy
Study Coordinator(s)Ana Maria Lopez, M.D., M.Ph, Sharon Wilczynski, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, CTSU Institutions in the United States
S0232Phase III

Memorandum

Double-Blinded Placebo Controlled Phase III Trial Comparing Dexamethasone (DEX) to the Combination of DEX + CC-5013 in Patients with Previously Untreated Multiple Myeloma who are Not Immediately Undergoing Autologous Stem Cell Transplant
Action CodesER
Study Coordinator(s)Jeffrey A. Zonder, M.D., Bart Barlogie, M.D.,Ph.D., Muneer H. Abidi, M.D.
ParticipantsMembers, NCORP, Medical Oncologists
S0325Phase IIb

Memorandum

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
S0331Phase II

Memorandum

A Phase II Trial of STI-571/Imatinib (GleevecĀ®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
Study Coordinator(s)Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, ECOG
S0345Phase II

Memorandum

A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
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
S0355Phase I

Memorandum

A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Study Coordinator(s)Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S0515Phase II

Memorandum

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

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