Clinical trial · Interventional
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma
- 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 determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Drug: cetuximab
- Drug: Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Every 3 months after subject off-treatment
Secondary outcomes (8)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry \[IHC\] (may be based on archival samples) and is metastatic. * Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer. * Prior fluoropyrimidine-containing regimen (5-fluorouracil \[5-FU\], capecitabine, or uracil/tegafur \[UFT\]), for the first-line treatment of metastatic disease. Exclusion Criteria: * A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy * Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease * Known or documented brain metastases
References
Publications (0)
Data not yet available