RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.
OBJECTIVES: Primary * Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan. Secondary * 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 regimen. 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 best response. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Response Proportion
Time frame: From registration until time of complete response or partial response
Duration of Response
Time frame: From registration until disease progression among patients who had at least a partial response.
Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
Time frame: From the day of first dose until the end of study, an average of 6 months
Progression-free Survival
Time frame: Time between registration and disease progression or death, whichever comes first.
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