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ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

NCT00415779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2010-02-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

docetaxel

given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2

DRUG

zoledronic acid

2 mg IV every 2 weeks

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Michele Caraglia, M.D. · Experimental Pharmacology, National Cancer Institute Naples

  • Alfredo Budillon, M.D. · Experimental Pharmacology, National Cancer Institute Naples

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  • R. Vincenzo Iaffaioli, M.D · Medical Oncology B, National Cancer Institute Naples

  • Gaetano Facchini, M.D. · Medical Oncology B, National Cancer Institute Naples

  • Alessandro Morabito, M.D. · Clinical Trials Unit, National Cancer Institute Naples

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-12-31
Completion
2009-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00415779 on ClinicalTrials.gov