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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00069888
Recruitment Status : Completed
First Posted : October 6, 2003
Last Update Posted : June 8, 2011
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients At High Risk of Relapse Following Prostatectomy
Study Start Date : November 2001
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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.)


  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069888

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United States, New Jersey
Sanofi-Aventis US
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: Yasir Nagarwala, M.D. Sanofi

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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00069888     History of Changes
Obsolete Identifiers: NCT00054509
Other Study ID Numbers: XRP6976J_2501
First Posted: October 6, 2003    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
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Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action