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

A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-type KRAS With and Without Detectable EGFR Expression

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637091

Enrollment

Registered

2008-03-17

Start date

2008-03-31

Completion date

2011-09-30

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Colorectal Cancer

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.

Interventions

DRUGCetuximab, irinotecan

cetuximab, irinotecan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Response rate	8 week

Secondary

Measure	Time frame
Progression free survival, overall survival	every 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026