A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer
I. Determine the efficacy of ixabepilone (BMS-247550) vs mitoxantrone and prednisone, in
terms of decline in prostate-specific antigen (PSA) levels, in patients with
taxane-resistant, hormone-refractory metastatic prostate cancer.
I. Determine the safety of these regimens in these patients. II. Determine the objective
response rate in patients with measurable disease who are treated with these regimens.
III. Determine the clinical activity of each of these regimens after crossover in patients
who experience disease progression on their originally assigned treatment arm and switch to
the other treatment arm.
OUTLINE: This is a randomized, crossover, multicenter study. Patients are stratified
according to ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2
ARM I: Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
ARM II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice
daily on days 1-21.In both arms, courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Patients who progress while on treatment after at least 2 courses or discontinue treatment
for any other reason may cross over to the other arm and receive treatment as above,
beginning within 12 weeks of last study treatment on original arm.
Patients are followed every 3 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria
The frequency of response with 95% confidence limits for a binomial outcome will be calculated.
Up to 3 months
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|