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

This study is currently recruiting participants.

Verified by Asan Medical Center, March 2009

First Received: March 10, 2008 Last Updated: March 3, 2009 History of Changes

Sponsored by:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00637091

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	40
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EGFR expression: Experimental Patients' accrual will be adjusted by EGFR expression (positive vs. negative)	Drug: Cetuximab, irinotecan cetuximab, irinotecan

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

Contacts

Contact: Tae Won Kim, MD

82-2-3010-3210

twkimmd@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138736
Contact: Tae Won Kim, MD 82-2-3010-3210 twkimmd@amc.seoul.kr

Sponsors and Collaborators

Asan Medical Center

More Information

No publications provided

Responsible Party:	Asan Medical Center ( Asan Medical Center )
Study ID Numbers:	AMC-ONCGI-2008-0031
Study First Received:	March 10, 2008
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00637091 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Mitogens
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009