Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer

Phase 1

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00064610
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate how safe PS-341(VELCADE) is when given with Docetaxel (Taxotere) to patients with androgen-independent prostate cancer, and also to see what effects (good and bad) it has on you and on your cancer.

Detailed Description

This is a dose escalation study, which means that the first group of patients will receive a low dose of PS-341 (VELCADE) and Docetaxel (Taxotere). If the low dose of VELCADE and Taxotere appears to be safe, then the next group of patients will receive a higher dose of VELCADE and Taxotere.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-07-10
• Study First Submitted QC: 2003-07-10
• Study First Posted: 2003-07-11
• Primary Completion: 2004-12
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-07
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (4)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Columbia-Presbyterian Hospital; 🇺🇸 New York, New York, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States