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

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Advanced Colorectal Cancer

Treatments

Drug: Cetuximab, irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00637091

AMC-ONCGI-2008-0031

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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