Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Trial of Trastuzumab (Herceptin; NSC #688097, IND #6667) in Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma
Phase II trial to study the effectiveness of trastuzumab in treating patients who have previously treated, locally advanced, or metastatic cancer of the urothelium. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
OBJECTIVES:
I. Determine the response rate in patients with previously treated, locally advanced or
metastatic transitional cell carcinoma of the urothelium treated with trastuzumab
(Herceptin).
II. Determine the safety of this drug in this patient population. III. Determine overall and
progression-free survival of this patient population treated with this drug.
OUTLINE:
Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of
week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes weekly.
Treatment may continue for more than 1 year in the absence of unacceptable toxicity or
disease progression.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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