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) - Tabular View

Tracking Information

First Received Date ^ICMJE

July 19, 2005

Last Updated Date

March 21, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall Survival Time [ Time Frame: various timepoints ]

Original Primary Outcome Measures ^ICMJE

Overall Survival Time

Change History

Complete list of historical versions of study NCT00122460 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Best overall response
Disease control
Duration of response
Time to treatment failure
Progression-free survival time
Safety
Quality of life assessments

Descriptive Information

Brief Title ^ICMJE

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)

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

442

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00122460

Responsible Party

Study ID Numbers ^ICMJE

EMR 62202-002

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jan B. Vermorken, Prof.

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

Information Provided By

Merck KGaA

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP