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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Given IV
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States
The proportion of patients with clinical response measured using RECIST criteria
Time frame: Up to 3 years
Toxicity graded using the NCI CTC version 2.0
Time frame: Up to 30 days after completion of study treatment
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