Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,221

Participants

Timeline

Start Date

May 31, 2004

Primary Completion Date

December 31, 2006

Study Completion Date

March 31, 2011

Conditions
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Interventions
DRUG

Cetuximab

Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Number of Cycles: until progression or unacceptable toxicity develops

DRUG

FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

Trial Locations (154)

Unknown

Research Site, Buenos Aires

Research Site, Bedford Park

Research Site, Darlinghurst

Research Site, Heidelberg

Research Site, Nedlands

Research Site, West Perth

Research Site, Woodville

Research Site, Innsbruck

Research Site, Klagenfurt

Research Site, Kufstein

Research Site, Salzburg

Research Site, Sankt Pölten

Research Site, Sankt Veit an der Glan

Research Site, Vienna

Research Site, Wels

Research Site, Antwerp

Research Site, Bonheiden

Research Site, Brussels

Research Site, Edegem

Research Site, Ghent

Research Site, Leuven

Research Site, Liège

Research Site, Goiânia

Research Site, Porto Alegre

Research Site, Santo André

Research Site, São Paulo

Research Site, Pleven

Research Site, Plovidiv

Research Site, Sofia

Research Site, Varna

Research Site, Santiago-Las Condes

Research Site, Santiago-Providencia

Research Site, Chomutov

Research Site, Prague

Research Site, Turku

Research Site, Bordeaux

Research Site, Boulogne-Billancourt

Research Site, Colmar

Research Site, Grenoble

Research Site, La Roche-sur-Yon

Research Site, Lorient

Research Site, Marseille

Research Sites, Nantes

Research Site, Périgueux

Research Site, Rennes

Research Site, Saint-Grégoire

Research Site, Strasbourg

Research Site, Toulon

Research Site, Villejuif

Research Site, Dortmund

Research Site, Dresden

Research Site, Düsseldorf

Research Site, Essen

Research Site, Frankfurt am Main

Research Site, Freiburg im Breisgau

Research Site, Göttingen

Research Site, Halle

Research Site, Hamburg

Research Site, Heidelberg

Research Site, Homburg/Saar

Research Site, Jena

Research Site, Mainz

Research Site, Mannheim

Research Site, München

Research Site, Oldenburg

Research Site, Ulm

Research Site, Alexandroupoli

Research Site, Athens

Research Site, Heraklion

Research Site, Pokfulam

Research Site, Shatin

Research Site, Budapest

Research Site, Debrecen

Research Site, Győr

Research Site, Kecskemét

Research Site, Pécs

Research Site, Ancona

Research Site, Aviano

Research Site, Bari

Research Site, Benevento

Research Site, Florence

Research Site, Mantova

Research Site, Milan

Research Site, Modena

Research Site, Napoli

Research Site, Reggio Emilia

Research Site, Roma

Research Site, Rozzano

Research Site, México

Research Site, Amsterdam

Research Site, Apeldoom

Research Site, Blaricum

Research Site, Roosendaal

Research Site, The Hague

Research Site, Zwolle

Research Site, Bialystok

Research Site, Gliwice

Research Site, Krakow

Research Site, Opole

Research Site, Poznan

Research Site, Warsaw

Research Site, Wroclaw

Research Site, Cluj-Napoca

Research Site, Iași

Research Site, Suceava

Research Site, Moscow

Research Site, Saint Petersburg

Research Site, Yaroslavl

Research Site, Singapore

Research Site, Banská Bystrica

Research Site, Bratislava

Research Site, Košice

Research Site, Trnava

Research Site, Žilina

Research Site, Cape Town

Research Site, Durban

Research Site, Johannesburg

Research Site, Port Elizabeth

Research Site, Pretoria

Research Site, Seoul

Research Site, A Coruña

Research Site, Barcelona

Research Site, Cadiz

Research Site, Madrid

Research Site, Palma de Mallorca

Research Site, Valencia

Research Site, Gothenburg

Research Site, Stockholm

Research Site, Changhua

Research Site, Chiayi City

Research Site, Taipei

Research Site, Taoyuan District

Research Site, Ankara

Research Site, Istanbul

Research Site, Izmir

Research Site, Charkassy

Research Site, Donetsk

Research Site, Ivano-Frankivsk

Research Site, Kiev

Research Site, Kryvyi Rih

Research Site, Luhansk

Research Site, Lviv

Research Site, Uzhhorod

Research Site, Zhaporozhye

Research Site, Brighton

Research Site, Cambridge

Research Site, Glasgow

Research Site, Guildford

Research Site, Kent

Research Site, Leicester

Research Site, London

Research Site, Peterborough

Research Site, Rhyl

Research Site, Sutton

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00154102 - Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) | Biotech Hunter | Biotech Hunter