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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 after failure to irinotecan in an exploratory manner.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Camptothecin; Cetuximab; Irinotecan

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