Prostate Cancer Clinical Trial
Official title:
Phase II Study of Herceptin (Recombinant Humanized Anti-p185HER2 Monoclonal Antibody) for the Treatment of Androgen Independent Prostate Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who
have prostate cancer that has not responded to hormone therapy.
OBJECTIVES: I. Assess the activity of trastuzumab (Herceptin) in patients with progressive
androgen dependent and independent prostate cancer. II. Study HER2 status by
immunohistochemistry on prostate cancer biopsy samples. III. Study associations between HER2
protein expression on tumor cells and post-therapy changes in PSA in this patient
population.
OUTLINE: Patients receive trastuzumab IV over 30 or 90 minutes once a week. Treatment
continues for a maximum of 24 weeks in the absence of unacceptable toxicity or disease
progression. Patients are followed for time to progression.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 6-9
months.
;
Primary Purpose: Treatment
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