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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00069888

Public ClinicalTrials.gov record NCT00069888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 20, 2026, 3:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00069888
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
83 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2001
Primary completion
Dec 31, 2006
Completion
Dec 31, 2006
Last update posted
Jun 7, 2011

2001 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Sanofi-Aventis US Bridgewater New Jersey 08807

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00069888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 7, 2011 · Synced Sep 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00069888 live on ClinicalTrials.gov.

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