Bone Metastases Clinical Trial
Official title:
Randomized Phase II Trial of BMS-275291 (NSC 713763, IND 62573) in Hormone Refractory Prostate Cancer
BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy
PRIMARY OBJECTIVES:
I. To assess the time to disease progression in patients with hormone-refractory prostate
cancer treated with two different doses of BMS-275291.
SECONDARY OBJECTIVES:
I. To assess the overall survival of patients with hormone-refractory prostate cancer
treated with two different doses of BMS-275291.
II. To assess the rate of response to BMS-275291, using both PSA and measurable disease.
III. To evaluate the qualitative and quantitative toxic effects of this agent in this
patient population.
IV. To investigate the correlation of tumor response with changes in the levels of serum
osteocalcin, alkaline phosphatase, procollagen I carboxy-terminal propeptide (PICP),
procollagen I amino-terminal propeptide (PINP), and N-telopeptide; and the correlation of
tumor response with changes in the levels of urine pyridinoline and deoxypyridinoline.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Gleason score (2-4 vs 5-7 vs 8-10), PSA level (less than 10 ng/mL vs 10-50 ng/mL vs 51-100
ng/mL vs more than 100 ng/mL), and concurrent bisphosphonate therapy (yes vs no). Patients
are randomized to one of two treatment arms.
ARM I: Patients receive oral BMS-275291 once daily on days 1-28.
ARM II: Patients receive oral BMS-275291 twice daily on days 1-28.
In both arms, treatment repeats every 28 days for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving a complete response (CR)
receive 2 additional courses beyond CR.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 24-68 patients (12-34 per treatment arm) will be accrued for
this study within 5-14 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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