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

NCT00069888 | Completed Phase 2

• 1 other identifier: XRP6976J_2501
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis US

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Yasir Nagarwala, M.D.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2003
• First Posted: October 6, 2003
• Study Start: November 1, 2001
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)