Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

June 30, 2008

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Cetuximab

Dose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg/m² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg/m² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg/m² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg/m² 400 400 400 400 5-FU Infusion 46.0 mg/m² 3200 3200 3200 3200

Trial Locations (3)

45112

Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Essen

68167

Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik, Mannheim

01307

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik, Dresden

All Listed Sponsors
lead

Technische Universität Dresden

OTHER

NCT00422773 - Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter