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)
NCT ID: NCT00122460
Last Updated: 2014-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2004-12-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cetuximab Plus Chemotherapy
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
Chemotherapy alone
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* Recurrent and/or metastatic SCCHN, not suitable for local therapy
Exclusion Criteria
* Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
* Nasopharyngeal carcinoma
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Research Site
Innsbruck, , Austria
Research Site
Vienna, , Austria
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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České Budějovice, , Czechia
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Prague, , Czechia
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Caen, , France
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Dijon, , France
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Lille, , France
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Limoges, , France
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Marseille, , France
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Montpellier, , France
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Nantes-Saint Herblain, , France
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Nice, , France
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Strasbourg, , France
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Toulouse, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Essen, , Germany
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Frankfurt on the Main, , Germany
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Hamburg, , Germany
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Munich, , Germany
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Oldenburg, , Germany
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Stuttgart, , Germany
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Budapest, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Cuneo, , Italy
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Genoa, , Italy
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Milan, , Italy
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Monserrato, , Italy
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Naples, , Italy
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Rome, , Italy
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Amsterdam, , Netherlands
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Nijmegen, , Netherlands
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Gdansk, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Lisbon, , Portugal
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Porto, , Portugal
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Moscow, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Lind, , Sweden
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Örebo, , Sweden
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Umeå, , Sweden
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Geneva, , Switzerland
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Thun, , Switzerland
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Zurich, , Switzerland
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Sumy, , Ukraine
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Chelmsford, , United Kingdom
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Edinburgh, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
Countries
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References
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Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.
Mesia R, Rivera F, Kawecki A, Rottey S, Hitt R, Kienzer H, Cupissol D, De Raucourt D, Benasso M, Koralewski P, Delord JP, Bokemeyer C, Curran D, Gross A, Vermorken JB. Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol. 2010 Oct;21(10):1967-1973. doi: 10.1093/annonc/mdq077. Epub 2010 Mar 24.
Hecht M, Hahn D, Wolber P, Hautmann MG, Reichert D, Weniger S, Belka C, Bergmann T, Gohler T, Welslau M, Grosse-Thie C, Guntinas-Lichius O, von der Grun J, Balermpas P, Orlowski K, Messinger D, Stenzel KG, Fietkau R. Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer. BMC Cancer. 2020 Sep 29;20(1):933. doi: 10.1186/s12885-020-07440-w.
Licitra L, Storkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.
Other Identifiers
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EMR 62202-002
Identifier Type: -
Identifier Source: org_study_id
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