Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients|
- Rate of Diarrhea [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- Progression free survival [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- Disease control rate [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: wXELIRI regimen||
Drug: irinotecan, capecitabine
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322152
|Fudan University Shanghai Cancer Center|
|Shanghai, Shanghai, China|
|Principal Investigator:||Jin Li, PhD||Fudan University|