This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 treatment arms. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
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.
Time frame: Up to 3 months
Frequency of any toxicity by grade
Time frame: Up to 3 months
Response duration
Will be estimated using the Kaplan-Meier product limit method.
Time frame: From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months
Time to progressive disease
Will be estimated using the Kaplan-Meier product limit method.
Time frame: From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months
Frequency of response to third-line (crossover) therapy
Estimates of response to third line treatment along with 95% confidence intervals will be calculated.
Time frame: Up to 3 months
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