Metastatic Prostate Cancer Clinical Trial
Official title:
Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy.
Docetaxel has been used alone and in combination with other anti-cancer therapies in the
treatment of hormone refractory metastatic prostate cancer. Zoledronic acid has been used in
the treatment of bone metastasis from prostate cancer. This is a study of the combination of
these two agents. The Zante study will test a dose escalation of docetaxel in association
with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6
and maximum of 12 cycles.
Sequence A: Docetaxel on day 1 and zoledronic acid on day 2
Sequence B: Zoledronic acid on day 1 and docetaxel on day 2
Patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36
patients will be enrolled.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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