drugset / Trial / NCT00153998

Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)

NCT00153998 ↗

Phase 2 Completed 135 enrolled Technical University Dresden
RandomizedParallel-groupOpen-labelTreatment

Summary

General Objectives: * To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection * To determine the optimal combination (cetuximab/FOLFOX versus cetuximab/FOLFIRI) for further trials in preoperative chemotherapy

Timeline

Start
2004-11
Primary completion
2008-03
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Comparator Irinotecan Small molecule 180 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 100 mg/m2 Intravenous
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 3000 mg/m2 Intravenous