Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- docetaxel
- Conditions
- Prostate Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 19
- Locations
- 3
- Primary Endpoint
- Complete Response Rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mary-Ellen Taplin, MD
Taplin, Mary-Ellen
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •No prior hormones, radiation or chemotherapy for prostate cancer
- •Evidence of serious active infection
Arms & Interventions
Docetaxel
Docetaxel given via iv at determined dose once a week for 4 weeks
Intervention: docetaxel
Outcomes
Primary Outcomes
Complete Response Rate
Time Frame: 2 Months, 6 Months
Wilcoxon Signed Rank Test
Secondary Outcomes
- Percentage of Participants with mild to moderate toxicity(6 months)