Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

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.

Inclusion Criteria:

• Signed informed consent
• Histologically confirmed colorectal cancer
• Age 18-70 years old
• Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
• Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• ECOG 0-1
• Life expectancy of more than 3 months.
• Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 100×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, AKP < 4×ULN

Exclusion Criteria:

• Pregnant or lactating patients
• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
• Active or uncontrolled infection
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
• Patients could not swallow the tablets
• Concomitant with brain metastases