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) - Full Text View

Sponsor:	Merck KGaA
Information provided by:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00122460

Purpose

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 who did not receive prior chemotherapy. Overall survival will be taken as the primary measure of efficacy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU Drug: Platinum (Cis or Carboplatin)+5FU	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin Carboplatin Cetuximab

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

Overall Survival Time [ Time Frame: various timepoints ]

Secondary Outcome Measures:

Best overall response [ Time Frame: various timepoints ]
Disease control [ Time Frame: various timepoints ]
Duration of response [ Time Frame: various timepoints ]
Time to treatment failure [ Time Frame: various timepoints ]
Progression-free survival time [ Time Frame: various timepoints ]
Safety [ Time Frame: various timepoints ]
Quality of life assessments [ Time Frame: various timepoints ]

Enrollment:	442
Study Start Date:	December 2004
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU Subjects in Group A will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/m2 (over 1 hour). All doses will be given by IV infusionSubjects in both treatment groups (A nad B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks
2: Active Comparator	Drug: Platinum (Cis or Carboplatin)+5FU All doses will be given by IV infusion/Subjects in both treatment groups (A and B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks

Arms

Assigned Interventions

1: Experimental

Drug: Cetuximab+Platinum (Cis or Carboplatin)+5FU

Subjects in Group A will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/m2 (over 1 hour). All doses will be given by IV infusionSubjects in both treatment groups (A nad B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks

2: Active Comparator

Drug: Platinum (Cis or Carboplatin)+5FU

All doses will be given by IV infusion/Subjects in both treatment groups (A and B) will receive either Cisplatin (100 mg/m2 on day 1)+5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) +5-FU (100 mg/m2 continuous IV from day 1 to day 4) every 3 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically and cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN)
Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122460

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Locations

Austria
Research Site
Wien, Austria
Research Site
Innsbruck, Austria
Belgium
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Edegem, Belgium
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Bruxelles, Belgium
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Gent, Belgium
Czech Republic
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Ceske Budejovice, Czech Republic
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Prague, Czech Republic
France
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Strasbourg, France
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Nantes-Saint Herblain, France
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Montpellier, France
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Caen, France
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Lille, France
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Marseille, France
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Vandoeuvre les Nancy, France
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Limoges, France
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Nice, France
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Tours, France
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Dijon, France
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Toulouse, France
Germany
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Essen, Germany
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Hamburg, Germany
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Frankfurt on the Main, Germany
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Stuttgart, Germany
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Oldenburg, Germany
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Munich, Germany
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Berlin, Germany
Hungary
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Nyiregyhaza, Hungary
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Gyor, Hungary
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Budapest, Hungary
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Kecskemet, Hungary
Italy
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Genova, Italy
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Cuneo, Italy
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Milan, Italy
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Monserrato, Italy
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Napoli, Italy
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Rome, Italy
Netherlands
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Amsterdam, Netherlands
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Nijmegen, Netherlands
Poland
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Warszawa, Poland
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Gdansk, Poland
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Krakow, Poland
Portugal
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Lisboa, Portugal
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Porto, Portugal
Russian Federation
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
Slovakia
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Kosice, Slovakia
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Bratislava, Slovakia
Spain
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Barcelona, Spain
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Madrid, Spain
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San Sebastian, Spain
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Santander, Spain
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Malaga, Spain
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L'Hospitalet de Llobregat, Spain
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Sevilla, Spain
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Valencia, Spain
Sweden
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Lund, Sweden
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Örebro, Sweden
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Umea, Sweden
Switzerland
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Bern, Switzerland
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Zürich, Switzerland
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Geneva, Switzerland
Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Sumy, Ukraine
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Kylv, Ukraine
United Kingdom
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London, United Kingdom
Research Site
Chelmsford, United Kingdom
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Nottingham, United Kingdom
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Manchester, United Kingdom
Research Site
Edinburgh, United Kingdom

Sponsors and Collaborators

Merck KGaA

Investigators

Principal Investigator:

Jan B. Vermorken, Prof.

University Hospital Antwerpen, 2650 Edegem, Department of Medical Oncology, Belgium

More Information

No publications provided by Merck KGaA

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	EMR 62202-002
Study First Received:	July 19, 2005
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00122460 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Merck KGaA:

Head and Neck Cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cetuximab
Carboplatin
Immunosuppressive Agents
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Head and Neck Neoplasms
Fluorouracil
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009