This phase II trial is studying how well ixabepilone works in treating patients with metastatic, recurrent, or unresectable kidney cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given IV
Correlative studies
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Objective response rate (partial or complete)
Time frame: Up to 5 years
Progression-free survival (PFS)
PFS rate will be estimated using the Kaplan-Meier method. Median PFS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.
Time frame: From the start of treatment to time of progression, assessed up to 5 years
Overall survival (OS)
OS rate will be estimated using the Kaplan-Meier method. Median OS time and its associated 90% confidence interval will be estimated using the method of Brookmeyer and Crowley.
Time frame: Up to 5 years
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