Prostate Cancer Clinical Trial
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
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.
Full 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.
Eligibility Criteria
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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
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