Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

PHASE2CompletedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

November 30, 2010

Conditions
Neoplasm MetastasisColorectal Cancer
Interventions
BIOLOGICAL

Cetuximab

"Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).~Until progression or unacceptable toxicity develops"

DRUG

Oxaliplatin

"Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks).~Until progression or unacceptable toxicity develops"

Trial Locations (78)

Unknown

Research Site, Graz

Research Site, Linz

Research Site, Salzburg

Research Site, Vienna

Research Site, Zams

Research Site, Antwerp

Research Site, Bonheiden

Research Site, Bruges

Research Site, Hasselt

Research Site, Leuven

Research Site, Roeselare

Research Site, Turnhout

Research Site, ZU Gent

Research Site, Besançon

Research Site, Clermond Ferrand

Research Site, Clichy

Research Site, Montpellier

Research Site, Paris

Research Site, Rouen

Research Site, Strasbourg

Research Site, Aschaffenburg

Research Site, Dresden

Research Site, Essen

Research Site, Hamburg

Research Site, Kiel

Research Site, Magdeburg

Research Site, Mannheim

Research Site, Nuremberg

Research Site, Tübingen

Research Site, Athens

Research Site, Loannina

Research Site, Thessaloniki

Research Site, Haifa

Research Site, Kfar Saba

Research Site, Petah Tikva

Research Site, Rehovot

Research Site, Tel Aviv

Research Site, Tel Litwinsky

Research Site, Brescia

Research Site, Milan

Research Site, Padua

Research Site, Pavia

Research Site, Rome

Research Site, Torino

Research Site, Bialystok

Research Site, Krakow

Research Site, Lublin

Research Site, Opole

Research Site, Poznan

Research Site, Szczecin

Research Site, Warsaw

Research Site, Lisbon

Research Site, Santa Maira Da Feira

Research Site, Alba Iulia

Research Site, Bucurest

Research Site, Onești

Research Site, Oradea

Research Site, Timișoara

Research Site, Kazan'

Research Site, Krasnodar

Research Site, Moscow

Research Site, Obninsk

Research Site, Saint Petersburg

Research Site, Samara

Research Site, Bilbao

Research Site, Burgos

Research Site, Girona

Research Site, Madrid

Research Site, Málaga

Research Site, Ourense

Research Site, Reus

Research Site, Valencia

Research Site, Dnipro

Research Site, Kharkiv

Research Site, Kiev

Research Site, Lviv

Research Site, Simferopol

Research Site, Vinnitsa

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00125034 - Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC) | Biotech Hunter | Biotech Hunter