Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: mitoxantrone hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer|
- Response to the randomized treatment as determined by > 50% PSA response as measured by RECIST criteria [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]The frequency of response with 95% confidence limits for a binomial outcome will be calculated.
- Frequency of any toxicity by grade [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: From the date PR or CR is first determined until the first evidence of progressive disease, assessed up to 3 months ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier product limit method.
- Time to progressive disease [ Time Frame: From the date protocol therapy is started until the first evidence of progressive disease, assessed up to 3 months ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier product limit method.
- Frequency of response to third-line (crossover) therapy [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]Estimates of response to third line treatment along with 95% confidence intervals will be calculated.
|Study Start Date:||March 2003|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
Experimental: 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.
Drug: mitoxantrone hydrochloride
Other Names:Drug: prednisone
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058084
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143-0875|
|Principal Investigator:||Jonathan Rosenberg||University of California, San Francisco|