Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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