Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
- Determine response in patients with locally advanced or metastatic transitional cell
carcinoma of the bladder treated with gemcitabine and irinotecan.
- Determine the duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes
on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.
Masking: Open Label, Primary Purpose: Treatment
Uzair B. Chaudhary, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|