The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.
Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Rate of Diarrhea
Time frame: eight weeks
Progression free survival
Time frame: eight weeks
Response rate
Time frame: eight weeks
Disease control rate
Time frame: eight weeks
Overall survival
Time frame: eight weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: eight weeks
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