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CELIM: Cetuximab Neoadjuvant in Colorectal Liver Metastases
NCT00153998Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2004
- Primary completion
- Mar 2008
- Countries
- 2
- Sponsor
- Technische Universität Dresden
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- cetuximab
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, randomised, open-label trial of cetuximab in colorectal cancer (CRC) (2 arms), sponsored by Technische Universität Dresden. Primary endpoint: Tumor response according to RECIST. Started Nov 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Cetuximab + FOLFIRI
Cetuximab with Irinotecan, 5-FU, and Folinic Acid
Cetuximab + FOLFOX
Cetuximab with Oxaliplatin, 5-FU, and Folinic Acid
03
Who it enrols
Patients with non-resectable colorectal liver metastases (>=5 metastases or technically non-resectable), age >= 18, KPS >= 80, adequate organ function. Excludes extrahepatic disease and prior EGFR therapy.
04
Endpoints
Primary
Tumor response according to RECIST
Secondary
Rate of R0 liver resection
Progression Free Survival
Disease Free Survival after resection
Overall Survival
Safety and Toxicity
Molecular predictive markers for response and toxicity
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