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
mg/2, respectively.
Response assessment will be performed every 3 cycles of chemotherapy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximal response rate and toxicities
During treatment
Kyung Hae Jung, M.D.
Principal Investigator
Korea: Food and Drug Administration
NCCCTS-01-024
NCT00506168
November 2001
July 2007
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