- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005096
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Eligibility Criteria:
- 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
- CALGB 0-1
- WBC greater than 3,000/mm3
- Hematocrit greater than 30%
- Platelet count greater than 100,000/mm3
- SGOT, total bilirubin within normal limits
- Signed Informed consent
Exclusion Criteria:
- No prior hormones, radiation or chemotherapy for prostate cancer
- Evidence of serious active infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Docetaxel
Docetaxel given via iv at determined dose once a week for 4 weeks
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response Rate
Time Frame: 2 Months, 6 Months
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Wilcoxon Signed Rank Test
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2 Months, 6 Months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with mild to moderate toxicity
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-193
- P30CA006516 (U.S. NIH Grant/Contract)
- DFCI-99193
- NCI-G00-1757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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