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

COMPLETEDPHASE2

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

NCT00637091•Asan Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

March 1, 2008

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2011

Last Updated

January 22, 2021

Enrollment

ACTUAL participants

Conditions

Advanced Colorectal Cancer

Interventions

Cetuximab, irinotecan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

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Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

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