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

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00468169

Run by

University of Chicago

People needed

110

Starts

2006-07-01

Expected to finish

2012-11-01

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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