Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression|
- Response rate [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]
- Progression free survival, overall survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: EGFR expression
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
Drug: Cetuximab, irinotecan
Other Name: PharmDx kit for EGFR staining.
Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.