Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00089128|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : April 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
- Duration of response
- Median and progression-free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089128
|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|