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Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Active

18 and over

Other

14401A
NCT00468169

Trial Description

Summary

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Eligibility Criteria

Inclusion Criteria:

Age 18 or older

Stage III and IV head and neck cancer

Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area

No prior chemotherapy or radiotherapy

Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Normal organ and marrow function

Exclusion Criteria:

Unequivocal demonstration of metastatic disease

Known severe hypersensitivity to drugs used in the study

Treatment with a non-approved or investigational drug within 30 days before Day 1

Incomplete healing from previous surgery

Pregnancy or breast feeding

Uncontrolled intercurrent illness including

Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF

Acute hepatitis or known HIV

Severe baseline neurologic deficits

Prior therapy which specifically and directly targets the EGFR pathway

Prior severe infusion reaction to a monoclonal antibody

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Chicago Cancer Research Center

Bristol-Myers Squibb Company - New York

Everett E Vokes, MD

Principal Investigator

Allison Dekker, R.N.		Ph: 773-702-2068
		Email: adekker@medicine.bsd.uchicago.edu

Rosalyn Williams		Ph: 773-702-0712
		Email: rwilliam@medicine.bsd.uchicago.edu

Trial Sites

U.S.A.

Illinois

Chicago

University of Chicago Cancer Research Center

Allison Dekker, RN Ph: 773-702-2068

Email: adekker@medicine.bsd.uchicago.edu

Rosalyn Williams Ph: 773-702-0712

Email: rwilliam@medicine.bsd.uchicago.edu

Everett E Vokes, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00468169
Information obtained from ClinicalTrials.gov on July 16, 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.