Clinical trial · Interventional
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
NCT00637091CI-TRIAL-00049576completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab, irinotecan | Drug | Cetuximab/Irinotecan Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGFR expression
- description
- Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
- interventionNames
- Drug: Cetuximab, irinotecan
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 8 week
Secondary outcomes (1)
- measure
- Progression free survival, overall survival
- timeFrame
- every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKang 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 21706149