Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Drug Therapy, Combination
Drug: Irinotecan, Capecitabine
|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 in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer|
- Maximal response rate and toxicities [ Time Frame: During treatment ]
- Progression-free survival and overall survival
|Study Start Date:||November 2001|
|Study Completion Date:||July 2007|
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.