An Open Label Phase IIa Trial Evaluating The Safety And Efficacy Of EP0906 As Therapy In Patients With Advanced Renal Cancer
- Determine whether epothilone B can produce a significant response (complete response
(CR) or partial response (PR)) as measured by tumor shrinkage in patients with advanced
- Determine the objective response rate and duration of response in patients with CR or
PR after treatment with this drug.
- Determine the time to disease progression and overall survival in patients treated with
- Determine the safety and tolerability of this drug in these patients.
- Determine genetic factors related to renal cancer that may predict response in patients
treated with this drug.
- Determine relative susceptibility to drug-drug interactions or serious side effects in
patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epothilone B IV over 5 minutes once weekly for three weeks. Courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 week and then every three months thereafter.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|