A Phase 1 interventional study of docetaxel and zoledronic acid in Metastatic Prostate Cancer, sponsored by National Cancer Institute, Naples. Completed at 2 sites in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-24.
Sponsored by National Cancer Institute, Naples · Phase 1, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 36 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
2 mg IV every 2 weeks
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
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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National Cancer Institute, Naples