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

Phase 2

Completed

• Conditions: Advanced Colorectal Cancer
• Interventions: Drug: Cetuximab, irinotecan

• Registration Number: NCT00637091
• Lead Sponsor: Asan Medical Center

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 after failure to irinotecan in an exploratory manner.

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-17
• Primary Completion: 2009-09
• Study Completion: 2011-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGFR expression	Cetuximab, irinotecan	Patients' accrual will be adjusted by EGFR expression (positive vs. negative)

Primary Outcome Measures

Name	Time	Method
Response rate	8 week

Secondary Outcome Measures

Name	Time	Method
Progression free survival, overall survival	every 8 weeks

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of