Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
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
to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules
every 2 weeks for up to 3 cycles
Michele Caraglia, M.D.
Experimental Pharmacology, National Cancer Institute Naples
Italy: Ethics Committee