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| Sponsored by: |
UMASS Memorial Cancer Center - University Campus |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003915 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the production of androgens.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel and estramustine plus hormone therapy in treating patients who have previously undergone radiation therapy or surgical removal of the prostate for stage I prostate cancer.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Docetaxel Estramustine Estramustine phosphate Estramustine phosphate sodium Leuprolide acetate Leuprolide Bicalutamide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment |
| Estimated Enrollment: | 55 |
| Study Start Date: | May 1999 |
OBJECTIVES:
OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses.
Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly every 3 months beginning on week 13. Treatment continues for 15 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months thereafter until disease progression.
PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
2 consecutively rising PSA levels at least 2 weeks apart, despite prior radical prostatectomy or radiotherapy (external beam or implant)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Must meet 1 of the following criteria:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | |||||
| Boston, Massachusetts, United States, 02215 | |||||
| Lahey Clinic - Burlington | |||||
| Burlington, Massachusetts, United States, 01805 | |||||
| University of Massachusetts Memorial Medical Center - University Campus | |||||
| Worcester, Massachusetts, United States, 01655 | |||||
| United States, New Hampshire | |||||
| Norris Cotton Cancer Center | |||||
| Lebanon, New Hampshire, United States, 03756-0002 | |||||
| UMASS Memorial Cancer Center - University Campus |
| Study Chair: | Mary-Ellen Taplin, MD | UMASS Memorial Cancer Center - University Campus |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067095, UMASS-H-3745, NCI-V99-1546 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003915 |
| Health Authority: | United States: Federal Government |
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