Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
Status and phase
Completed
Phase 3
Conditions
Colorectal Cancer
Treatments
Drug: cetuximab
Drug: Irinotecan
Details and patient eligibility
About
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.
Enrollment
1,302 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,302 participants in 2 patient groups
Arm A
Experimental group
Treatment:
Drug: cetuximab
Drug: Irinotecan
Drug: Irinotecan
Arm B
Active Comparator group
Treatment:
Drug: Irinotecan
Drug: Irinotecan
Trial contacts and locations
188
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Data sourced from clinicaltrials.gov
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