Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
- Determine the probability of response (confirmed complete and partial response) to
treatment with irinotecan in patients with recurrent or refractory advanced
transitional cell carcinoma of the urothelium previously treated with platinum-based
- Determine the qualitative and quantitative toxic effects of this drug in these
- Determine the overall and progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic
radiotherapy (yes vs no).
Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of response (confirmed complete and partial response)
From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Tomasz M. Beer, MD
OHSU Knight Cancer Institute
United States: Federal Government