A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer
OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of
patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10.
II. Determine the toxicity of this regimen in this patient population.
OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus
every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable
toxicity or disease progression. Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Hedy L. Kindler, MD
University of Chicago
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Lutheran General Cancer Care Center||Park Ridge, Illinois 60068|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Illinois Oncology Research Association||Peoria, Illinois 61602|