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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)

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Completed

18 and over

Pharmaceutical / Industry

EMR 62202-002
NCT00122460

Trial Description

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

Jan B. Vermorken, Prof.

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00122460
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.