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Sponsors and Collaborators: |
Sanofi-Aventis National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054509 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Docetaxel may kill any remaining tumor cells following surgery.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have undergone surgery for prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter, Open-Label, Phase II Trial of Adjuvant Taxotere in Patients at High Risk of Relapse Following Prostatectomy |
Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior prostatectomy within the past 4-8 weeks required
High risk of disease progression
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent alternative therapies including the following:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, New Jersey | |
Aventis Pharmaceuticals, Incorporated | |
Bridgewater, New Jersey, United States, 08807-2854 |
Study ID Numbers: | CDR0000270750, AVENTIS-XRP6976J/2501, RPCI-DS-0212 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054509 |
Health Authority: | United States: Federal Government |
stage I prostate cancer stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |