Spots Global Cancer Trial Database for ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer
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Trial Identification
Brief Title: ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer
Official Title: Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
Study ID: NCT00415779
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Istituto Nazionale dei Tumori, Napoli, , Italy
Ospedale Oncologico Regionale C.R.O.B. - Basilicata, Rionero in Vulture, , Italy
Contact Details
Name: Michele Caraglia, M.D.
Affiliation: Experimental Pharmacology, National Cancer Institute Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Alfredo Budillon, M.D.
Affiliation: Experimental Pharmacology, National Cancer Institute Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D
Affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Role: PRINCIPAL_INVESTIGATOR
Name: R. Vincenzo Iaffaioli, M.D
Affiliation: Medical Oncology B, National Cancer Institute Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Gaetano Facchini, M.D.
Affiliation: Medical Oncology B, National Cancer Institute Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandro Morabito, M.D.
Affiliation: Clinical Trials Unit, National Cancer Institute Naples
Role: PRINCIPAL_INVESTIGATOR
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