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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given IV
Cancer and Leukemia Group B
Chicago, Illinois, United States
Objective response rate (complete or partial response) as assessed by RECIST criteria
Time frame: 1 year
Toxicities as graded according to the NCI Common Toxicity Criteria
Time frame: 12 weeks
Proportion of patients who are HER2 positive (3+ by IHC or FISH positive)
Time frame: Baseline
Overall survival (OS)
Time frame: From date of initiation of treatment to date of death due to any cause, assessed up to 1 year
Disease-free survival (DFS)
Time frame: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 1 year
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