drugset / Trial / NCT01802645
Cetuximab/FOLFIRI With or Without Oxaliplatin and FOLFOXIRI With or Without Bevacizumab in Neoadjuvant Treatment of Non-resectable Colorectal Liver Metastases
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to investigate the following schedules for efficacy with regard to response rate in neoadjuvant treatment of patients with non-resectable liver metastases: * Cetuximab/FOLFOXIRI and cetuximab/FOLFIRI in patients with ras wild type tumours and * Bevacizumab/FOLFOXIRI and FOLFOXIRI in patients with ras mutant tumours.
Timeline
- Start
- 2013-03
- Primary completion
- 2019-09
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 165 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 3200 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |