Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and
safety of combination chemotherapy with irinotecan and capecitabine in previously untreated
metastatic colorectal cancer.
Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and
capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or
older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750
Response assessment will be performed every 3 cycles of chemotherapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximal response rate and toxicities
Kyung Hae Jung, M.D.
Korea: Food and Drug Administration