A Phase II Trial Of The Epothilone B Analog BMS-247550 (NSC 710428D) In Patients With Hepatobiliary Cancer
I. Determine the objective response rate of patients with hepatobiliary cancer treated with
II. Determine the toxicity of this drug in these patients. III. Determine the duration of
response, median and overall survival, and time to progression in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days for at
least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (partial or complete response) evaluated by RECIST
A 10% response rate precludes further study whereas a 25% response rate would indicate that further study is warranted.
Up to 8 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|