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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.
Sponsor:
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00637091
First received: March 10, 2008
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 8 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival, overall survival [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637091

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

Publications:

Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00637091     History of Changes
Other Study ID Numbers: AMC-ONCGI-2008-0031
Study First Received: March 10, 2008
Last Updated: July 16, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
 Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013