Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Colorectal Cancer
Interventions
DRUG

FOLFOX-4+cetuximab

"Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);~FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2"

DRUG

FOLFOX-4

FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2

Trial Locations (1)

28046

Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD), Madrid

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

NCT00202787 - Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer | Biotech Hunter | Biotech Hunter