A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma
I. Determine the objective response rate in patients with metastatic, recurrent, or
unresectable renal cell carcinoma treated with ixabepilone.
I. Determine the progression-free and overall survival rates in patients treated with this
II. Determine the toxicity of this drug in these patients. III. Correlate VHL gene mutations
with response in patients treated with this drug.
IV. Correlate VHL pathway protein expression with response in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 9 weeks until disease
progression and then every 3 months for up to 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (partial or complete)
Up to 5 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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