Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME)

PHASE3CompletedINTERVENTIONAL
Enrollment

442

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

March 31, 2007

Study Completion Date

January 31, 2011

Conditions
Head and Neck Cancer
Interventions
DRUG

Cetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU)

Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks

DRUG

Platinum (Cisplatin or Carboplatin) + 5-FU

All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks

Trial Locations (70)

Unknown

Research Site, Innsbruck

Research Site, Vienna

Research Site, Brussels

Research Site, Edegem

Research Site, Ghent

Research Site, České Budějovice

Research Site, Prague

Research Site, Caen

Research Site, Dijon

Research Site, Lille

Research Site, Limoges

Research Site, Marseille

Research Site, Montpellier

Research Site, Nantes-Saint Herblain

Research Site, Nice

Research Site, Strasbourg

Research Site, Toulouse

Research Site, Tours

Research Site, Vandœuvre-lès-Nancy

Research Site, Berlin

Research Site, Essen

Research Site, Frankfurt on the Main

Research Site, Hamburg

Research Site, Munich

Research Site, Oldenburg

Research Site, Stuttgart

Research Site, Budapest

Research Site, Győr

Research Site, Kecskemét

Research Site, Nyíregyháza

Research Site, Cuneo

Research Site, Genoa

Research Site, Milan

Research Site, Monserrato

Research Site, Naples

Research Site, Rome

Research Site, Amsterdam

Research Site, Nijmegen

Research Site, Gdansk

Research Site, Krakow

Research Site, Warsaw

Research Site, Lisbon

Research Site, Porto

Research Site, Moscow

Research Site, Saint Petersburg

Research Site, Bratislava

Research Site, Košice

Research Site, Barcelona

Research Site, Donostia / San Sebastian

Research Site, L'Hospitalet de Llobregat

Research Site, Madrid

Research Site, Málaga

Research Site, Santander

Research Site, Seville

Research Site, Valencia

Research Site, Lind

Research Site, Örebo

Research Site, Umeå

Research Site, Geneva

Research Site, Thun

Research Site, Zurich

Research Site, Donetsk

Research Site, Kharkiv

Research Site, Kiev

Research Site, Sumy

Research Site, Chelmsford

Research Site, Edinburgh

Research Site, London

Research Site, Manchester

Research Site, Nottingham

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00122460 - Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) | Biotech Hunter | Biotech Hunter