A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
OBJECTIVES:
I. Determine the response rate of patients with advanced carcinoma of the urothelium treated
with ixabepilone.
II. Assess the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients with clinical response measured using RECIST criteria
Up to 3 years
No
Robert Dreicer
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-02390
NCT00021099
June 2001
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |