Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.

PHASE2CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

June 30, 2009

Study Completion Date

May 31, 2012

Conditions
Previously Untreated Metastatic Colorectal Cancer
Interventions
DRUG

UFOX + Cetuximab

"* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)~* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)~* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"

DRUG

FOLFOX4 + Cetuximab

"* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)~* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)~* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16~* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16"

Trial Locations (57)

Unknown

Research Site, Buenos Aires

Research Site, Ciudad Autónoma Buenos Aires

Research Site, Perth

Research Site, Wollongong

Research Site, Graz

Research Site, Vienna

Research Site, Leuven

Research Site, Liège

Research Site, Belo Horizonte

Research site, Cep Sao Paulo-SP

Research Site, Fortaleza

Research Site, Besançon

Research Site, Caen

Research Site, La Roche-sur-Yon

Research Site, Lille

Research Site, Marseille

Research Site, Nice

Research Site, Saint-Herblain

Research Site, Strasbourg

Research Site, Berlin

Research Site, Dortmund

Research Site, Dresden

Research Site, Frankfurt am Main

Research Site, Hamburg

Research Site, Hanover

Research Site, Heidelberg

Research Site, Kassel

Research Site, Krefeld

Research Site, Magdeburg

Research Site, München

Research Site, Oldenburg

Research Site, Wiesbaden

Research Site, Dragana

Research Site, Thessaloniki

Research Site, Voútai

Research Site, Hong Kong

Research Site, Shatin

Research Site, Haifa

Research Site, Jerusalem

Research Site, Benevento

Research Site, Brescia

Research Site, Cremona

Research Site, Forlì

Research Site, Padua

Research Site, Pavia

Research Site, Potenza

Research Site, Reggio Emilia

Research Site, Rimini

Research Site, Roma

Research Site, Sassari

Research Site, Mexico City

Research Site, Krakow

Research Site, Lublin

Research Site, Opole

Research Site, Warsaw

Research Site, Bangkok

Research Site, Pathumwan

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00439517 - Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab. | Biotech Hunter | Biotech Hunter