NCT00506168

Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Secondary
• Drug Therapy, Combination

Interventions

Type	Name	Description
DRUG	Irinotecan, Capecitabine

Timeline

• Start date: 2001-11-01
• Completion: 2007-07-01
• First posted: 2007-07-25
• Last updated: 2007-07-25

Locations

1 site across 1 country: South Korea