NCT00415779

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	docetaxel	given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2
DRUG	zoledronic acid	2 mg IV every 2 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-12-01
• Completion: 2009-07-01
• First posted: 2006-12-25
• Last updated: 2010-02-24

Locations

2 sites across 1 country: Italy