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

January 17, 2021 updated by: Tae Won Kim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGFR expression
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
Drug: Cetuximab, irinotecan
cetuximab, irinotecan
Other Names:
  • PharmDx kit for EGFR staining.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: 8 week
8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival, overall survival
Time Frame: every 8 weeks
every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-ONCGI-2008-0031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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