Status:
COMPLETED
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Lead Sponsor:
Asan Medical Center
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
- Estimated life expectancy of more than 3 months
- ECOG performance status of 0 to 1 at study entry
- Adequate bone marrow function
- Adequate liver function
- Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
- Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
- Informed Consent
Exclusion
- Central nervous system (CNS) metastases or prior radiation for CNS metastases.
- Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
- Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
- Evidence of gastrointestinal bleeding
- Exposure to Cetuximab
- Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
- KRAS mutant Status
- Patients with serious toxicity to previous irinotecan-based chemotherapy
- Other serious illness or medical conditions
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00637091
Start Date
March 1 2008
End Date
September 1 2011
Last Update
January 22 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138736