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)

Last updated: July 11, 2014
Sponsor: Merck KGaA, Darmstadt, Germany
Overall Status: Completed

Phase

3

Condition

Nasopharyngeal Cancer

Lung Cancer

Head And Neck Cancer

Treatment

N/A

Clinical Study ID

NCT00122460
EMR 62202-002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of thehead and neck (SCCHN)

  • Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion

Exclusion Criteria:

  • Prior systemic chemotherapy, except if given as part of a multimodal treatment forlocally advanced disease which was completed more than 6 months prior to study entry

  • Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks beforestudy entry

  • Nasopharyngeal carcinoma

Study Design

Total Participants: 442
Study Start date:
December 01, 2004
Estimated Completion Date:
January 31, 2011

Connect with a study center

  • Research Site

    Innsbruck,
    Austria

    Site Not Available

  • Research Site

    Wien,
    Austria

    Site Not Available

  • Research Site

    Bruxelles,
    Belgium

    Site Not Available

  • Research Site

    Edegem,
    Belgium

    Site Not Available

  • Research Site

    Gent,
    Belgium

    Site Not Available

  • Research Site

    Ceske Budejovice,
    Czech Republic

    Site Not Available

  • Research Site

    Prague,
    Czech Republic

    Site Not Available

  • Research Site

    Caen,
    France

    Site Not Available

  • Research Site

    Dijon,
    France

    Site Not Available

  • Research Site

    Lille,
    France

    Site Not Available

  • Research Site

    Limoges,
    France

    Site Not Available

  • Research Site

    Marseille,
    France

    Site Not Available

  • Research Site

    Montpellier,
    France

    Site Not Available

  • Research Site

    Nantes-Saint Herblain,
    France

    Site Not Available

  • Research Site

    Nice,
    France

    Site Not Available

  • Research Site

    Strasbourg,
    France

    Site Not Available

  • Research Site

    Toulouse,
    France

    Site Not Available

  • Research Site

    Tours,
    France

    Site Not Available

  • Research Site

    Vandoeuvre les Nancy,
    France

    Site Not Available

  • Research Site

    Berlin,
    Germany

    Site Not Available

  • Research Site

    Essen,
    Germany

    Site Not Available

  • Research Site

    Frankfurt on the Main,
    Germany

    Site Not Available

  • Research Site

    Hamburg,
    Germany

    Site Not Available

  • Research Site

    Munich,
    Germany

    Site Not Available

  • Research Site

    Oldenburg,
    Germany

    Site Not Available

  • Research Site

    Stuttgart,
    Germany

    Site Not Available

  • Research Site

    Budapest,
    Hungary

    Site Not Available

  • Research Site

    Gyor,
    Hungary

    Site Not Available

  • Research Site

    Kecskemet,
    Hungary

    Site Not Available

  • Research Site

    Nyiregyhaza,
    Hungary

    Site Not Available

  • Research Site

    Cuneo,
    Italy

    Site Not Available

  • Research Site

    Genoa,
    Italy

    Site Not Available

  • Research Site

    Milan,
    Italy

    Site Not Available

  • Research Site

    Monserrato,
    Italy

    Site Not Available

  • Research Site

    Naples,
    Italy

    Site Not Available

  • Research Site

    Rome,
    Italy

    Site Not Available

  • Research Site

    Amsterdam,
    Netherlands

    Site Not Available

  • Research Site

    Nijmegen,
    Netherlands

    Site Not Available

  • Research Site

    Gdansk,
    Poland

    Site Not Available

  • Research Site

    Krakow,
    Poland

    Site Not Available

  • Research Site

    Warszawa,
    Poland

    Site Not Available

  • Research Site

    Lisbon,
    Portugal

    Site Not Available

  • Research Site

    Porto,
    Portugal

    Site Not Available

  • Research Site

    Moscow,
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Research Site

    Bratislava,
    Slovakia

    Site Not Available

  • Research Site

    Kosice,
    Slovakia

    Site Not Available

  • Research Site

    Barcelona,
    Spain

    Site Not Available

  • Research Site

    L'Hospitalet de Llobregat,
    Spain

    Site Not Available

  • Research Site

    Madrid,
    Spain

    Site Not Available

  • Research Site

    Malaga,
    Spain

    Site Not Available

  • Research Site

    San Sebastian,
    Spain

    Site Not Available

  • Research Site

    Santander,
    Spain

    Site Not Available

  • Research Site

    Sevilla,
    Spain

    Site Not Available

  • Research Site

    Valencia,
    Spain

    Site Not Available

  • Research Site

    Lind,
    Sweden

    Site Not Available

  • Research Site

    Umea,
    Sweden

    Site Not Available

  • Research Site

    Örebo,
    Sweden

    Site Not Available

  • Research Site

    Örebo,
    Sweden

    Site Not Available

  • Research Site

    Geneva,
    Switzerland

    Site Not Available

  • Research Site

    Thun,
    Switzerland

    Site Not Available

  • Research Site

    Zürich,
    Switzerland

    Site Not Available

  • Research Site

    Zürich,
    Switzerland

    Site Not Available

  • Research Site

    Donetsk,
    Ukraine

    Site Not Available

  • Research Site

    Kharkiv,
    Ukraine

    Site Not Available

  • Research Site

    Kiev,
    Ukraine

    Site Not Available

  • Research Site

    Sumy,
    Ukraine

    Site Not Available

  • Research Site

    Chelmsford,
    United Kingdom

    Site Not Available

  • Research Site

    Edinburgh,
    United Kingdom

    Site Not Available

  • Research Site

    London,
    United Kingdom

    Site Not Available

  • Research Site

    Manchester,
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham,
    United Kingdom

    Site Not Available

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