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

Advanced Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637091
• Other study ID #: AMC-ONCGI-2008-0031
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: September 2011

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Cetuximab, irinotecan
cetuximab, irinotecan

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kang MJ, Hong YS, Kim KP, Kim SY, Baek JY, Ryu MH, Lee JL, Chang HM, Kim MJ, Chang HJ, Kang YK, Kim TW. Biweekly cetuximab plus irinotecan as second-line chemotherapy for patients with irinotecan-refractory and KRAS wild-type metastatic colorectal cancer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		8 week
Secondary	Progression free survival, overall survival		every 8 weeks