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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005096 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer |
| Study Start Date: | December 1999 |
OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.
OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Potential candidate for radical prostatectomy Any of the following: Clinical stage T3 patients Serum PSA at least 20 ng/mL Gleason score 8-10 Clinical T2 disease and either of the following: MRI evidence of seminal vesicle involvement Gleason 4+3 cancer with either 5 or 6 biopsies positive
PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: CALGB 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Hematocrit greater than 30% Platelet count greater than 100,000/mm3 Hepatic: SGOT and bilirubin normal Renal: Not specified Other: No active infection Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: See Disease Characteristics No prior surgery for prostate cancer
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | William Oh, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000067764, DFCI-99193, NCI-G00-1757 |
| Study First Received: | April 6, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005096 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage II prostate cancer stage III prostate cancer |
|
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
|
Docetaxel Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents |
Therapeutic Uses Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |
