Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Launched by ASAN MEDICAL CENTER · Mar 10, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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