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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00069888
First received: October 2, 2003
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: Docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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

Enrollment: 83
Study Start Date: November 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069888

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

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00069888     History of Changes
Obsolete Identifiers: NCT00054509
Other Study ID Numbers: XRP6976J_2501
Study First Received: October 2, 2003
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013