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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637091
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
Tae Won Kim, 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.

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: Cetuximab, irinotecan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Response rate [ Time Frame: 8 week ]

Secondary Outcome Measures :
  1. Progression free survival, overall survival [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637091

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736
Sponsors and Collaborators
Asan Medical Center

Publications of Results:
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Responsible Party: Tae Won Kim, Professor, Asan Medical Center Identifier: NCT00637091     History of Changes
Other Study ID Numbers: AMC-ONCGI-2008-0031
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological