Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 10, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 22, 2021
January 1, 2021
1.5 years
March 10, 2008
January 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
8 week
Secondary Outcomes (1)
Progression free survival, overall survival
every 8 weeks
Study Arms (1)
EGFR expression
EXPERIMENTALPatients' accrual will be adjusted by EGFR expression (positive vs. negative)
Interventions
cetuximab, irinotecan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Central nervous system (CNS) metastases or prior radiation for CNS metastases.
- Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138736, South Korea
Related 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 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.
PMID: 21706149RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 10, 2008
First Posted
March 17, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2011
Last Updated
January 22, 2021
Record last verified: 2021-01