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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

This study has been completed.
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center Identifier:
First received: March 10, 2008
Last updated: July 17, 2014
Last verified: July 2014
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 Intervention Phase
Advanced Colorectal Cancer Drug: Cetuximab, irinotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Tae Won Kim, Asan Medical Center:

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

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

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00637091

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

Responsible Party: Tae Won Kim, Professor, Asan Medical Center Identifier: NCT00637091     History of Changes
Other Study ID Numbers: AMC-ONCGI-2008-0031
Study First Received: March 10, 2008
Last Updated: July 17, 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017