Viewing Study NCT00506168



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Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00506168
Status: TERMINATED
Last Update Posted: 2007-07-25
First Post: 2007-07-23

Brief Title: Study of Irinotecan Capecitabine in Metastatic Colorectal Cancer
Sponsor: National Cancer Center Korea
Organization: National Cancer Center Korea

Study Overview

Official Title: Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer
Status: TERMINATED
Status Verified Date: 2007-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The study drugs are not covered anymore by insurance
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 mgm2 on day 1 and 8 and capecitabine 1000mgm2 twice daily from day 1 to 14 every 3 weeksFor patiens equal to or older then 65 doses of irinotecan and capecitabine will be reduced to 60 mgm2 and 750 mg2 respectively

Response assessment will be performed every 3 cycles of chemotherapy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None