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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
2 mg IV every 2 weeks
Istituto Nazionale dei Tumori
Naples, Italy
Ospedale Oncologico Regionale C.R.O.B. - Basilicata
Rionero in Vulture, Italy
to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules
Time frame: every 2 weeks for up to 3 cycles
to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies
Time frame: every 2 weeks for 6 cycles
to determine which administration sequence of the combination permits a higher dosage of docetaxel
Time frame: every 2 weeks for 6 weeks
to describe the toxicity of the combination of the two drugs
Time frame: every 2 weeks
to describe the effects of the combination of the two drugs on biologic parameters: angiogenetic factors, cytokines, differential neuroendocrine markers, serum markers of osteolysis
Time frame: every 12 weeks
to describe the antitumor activity of the two drug association
Time frame: every 12 weeks
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