Back to resultsEfficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Primary Purpose
Advanced Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cetuximab, irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Cancer
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EGFR expression
Arm Description
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Progression free survival, overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637091
Brief Title
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
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 Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EGFR expression
Arm Type
Experimental
Arm Description
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
Intervention Type
Drug
Intervention Name(s)
Cetuximab, irinotecan
Other Intervention Name(s)
PharmDx kit for EGFR staining.
Intervention Description
cetuximab, irinotecan
Primary Outcome Measure Information:
Title
Response rate
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Progression free survival, overall survival
Time Frame
every 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21706149
Citation
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 according to epidermal growth factor receptor expression status. Invest New Drugs. 2012 Aug;30(4):1607-13. doi: 10.1007/s10637-011-9703-8. Epub 2011 Jun 25.
Results Reference
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Learn more about this trial
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
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