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

Tracking Information

First Received Date ^ICMJE

October 2, 2003

Last Updated Date

July 21, 2008

Start Date ^ICMJE

November 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069888 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: Docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

INCLUSION CRITERIA:

patients with prostate cancer who have just undergone prostatectomy,
high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.)

EXCLUSION CRITERIA:

Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
Prior radiation therapy
Patients receiving any concurrent therapy for cancer. This includes alternative therapies
Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids.
History of a malignancy other than prostate cancer
Peripheral neuropathy >/= Grade 2
Psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol
Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00069888

Responsible Party

Study ID Numbers ^ICMJE

XRP6976J/2501

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Yasir Nagarwala, M.D.

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP