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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054509 |
Purpose
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.
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | CDR0000270750, AVENTIS-XRP6976J/2501, RPCI-DS-0212 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00054509 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer stage III prostate cancer adenocarcinoma of the prostate |
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Genital Neoplasms, Male Prostatic Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Urogenital Neoplasms |
Genital Diseases, Male Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |