A Phase II, Open-Label, Randomized Trial of Zoledronic Acid (Zometa™) and BMS-275291 (NSC#713763) in Patients With Hormone Refractory Prostate Cancer
I. To evaluate the confirmed response rate of hormone refractory prostate cancer patients
treated with Zometa with BMS-275291.
I. To evaluate the toxicity profile associated with this treatment in this patient
II. To evaluate the overall and progression-free survival associated with this treatment
III. To explore changes markers for bone turnover, fPYR, fDPYR, and serum samples for
cross-linked N-telopeptides from baseline.
IV. To assess changes in bone tumor metabolism after treatment using PET scans. V. To assess
changes in MMP-1, MMP-9, VEGF and bFGF from baseline after treatment.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
prior chemotherapy (yes vs no) and participating center.
ARM I: Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291
daily on days 1-28.
ARM II (CLOSED TO ACCRUAL AS OF 10/10/2003): Patients receive zoledronate as in Arm I.
In both arms, courses repeat every 28 days in the absence of disease progression or
Patients are followed every 3 months until disease progression and then every 6 months for
up to 2 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response (PSA decline of greater than 50% confirmed at least four weeks apart)
Up to 2 years
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|