Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
- Registration Number
- NCT00005096
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
Not provided
- No prior hormones, radiation or chemotherapy for prostate cancer
- Evidence of serious active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel docetaxel Docetaxel given via iv at determined dose once a week for 4 weeks
- Primary Outcome Measures
Name Time Method Complete Response Rate 2 Months, 6 Months Wilcoxon Signed Rank Test
- Secondary Outcome Measures
Name Time Method Percentage of Participants with mild to moderate toxicity 6 months
Trial Locations
- Locations (3)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States