Trastuzumab in Treating Patients With 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Herceptin (Recombinant Humanized Anti-p185HER2 Monoclonal Antibody) for the Treatment of Androgen Independent Prostate Cancer|
|Study Start Date:||October 1998|
|Study Completion Date:||September 2002|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Howard I. Scher, MD||Memorial Sloan-Kettering Cancer Center|