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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.
First Received: October 2, 2003   Last Updated: July 21, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00069888
  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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:


Further study details as provided by Sanofi-Aventis:

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

Estimated Enrollment: 77
Study Start Date: November 2001
  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-Aventis
Investigators
Study Director: Yasir Nagarwala, M.D. Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Study ID Numbers: XRP6976J/2501
Study First Received: October 2, 2003
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00069888     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Adjuvants, Immunologic
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

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

ClinicalTrials.gov processed this record on July 02, 2009