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)
Cetuximab 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
1 other identifier
interventional
442
17 countries
70
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 head-and-neck-cancer
Started Dec 2004
Typical duration for phase_3 head-and-neck-cancer
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
September 30, 2011
CompletedJuly 23, 2014
July 1, 2014
2.2 years
July 19, 2005
August 25, 2011
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival Time (OS)
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Secondary Outcomes (8)
Progression-free Survival Time (PFS)
time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Best Overall Response
evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Disease Control
evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Time to Treatment Failure
Time from randomization to treatment failure or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
Duration of Response
time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007
- +3 more secondary outcomes
Study Arms (2)
Cetuximab Plus Chemotherapy
EXPERIMENTALChemotherapy alone
ACTIVE COMPARATORInterventions
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
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
You may qualify if:
- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
- Recurrent and/or metastatic SCCHN, not suitable for local therapy
You may not qualify if:
- Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry
- Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
- Nasopharyngeal carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Research Site
Innsbruck, Austria
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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
Research Site
Nottingham, United Kingdom
Related Publications (4)
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.
PMID: 18784101RESULTMesia 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.
PMID: 20335368RESULTHecht 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.
PMID: 32993574DERIVEDLicitra 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.
PMID: 23265711DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Non-specific outcome measures 'Safety' \& 'QOL assessments' were deleted from this entry in error.Replacement outcomes have been created. The 'Safety' outcome refers to adverse events.
Results Point of Contact
- Title
- Inmaculada Ollero/Clinical Trial Manager
- Organization
- Merck Serono
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2005
First Posted
July 22, 2005
Study Start
December 1, 2004
Primary Completion
March 1, 2007
Study Completion
January 1, 2011
Last Updated
July 23, 2014
Results First Posted
September 30, 2011
Record last verified: 2014-07