Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

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