A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00069888
• Lead Sponsor: Sanofi

Brief Summary

This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy.

Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor.

All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2003-10-02
• Study First Submitted QC: 2003-10-03
• Study First Posted: 2003-10-06
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the preliminary effects of six cycles of adjuvant, weekly Taxotere® (three weeks on/one week off) on the rate of progression-free survival

Trial Locations

Locations (1)

Sanofi-Aventis US; 🇺🇸 Bridgewater, New Jersey, United States