Spots Global Cancer Trial Database for Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

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Trial Identification

Brief Title: Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

Official Title: Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer

Study ID: NCT00506168

Conditions

Colorectal Neoplasms

Secondary

Drug Therapy, Combination

Interventions

Irinotecan, Capecitabine

Study Description

Brief Summary: This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Detailed Description: 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 mg/2, respectively. Response assessment will be performed every 3 cycles of chemotherapy.