A Phase II Trial of BMS 247550 (Ixabepilone) in Advanced Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with metastatic, recurrent, or
unresectable renal cell carcinoma treated with ixabepilone.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival rates in patients treated with this
drug.
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
drug.
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.
Interventional
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
No
Edwin Posadas
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02669
NCT00182702
July 2005
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |