Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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.
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer|
- Response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Tolerance [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Median and progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||November 2001|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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 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.
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Uzair B. Chaudhary, MD||Medical University of South Carolina|