Status:
COMPLETED
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ne...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00468169
Start Date
July 1 2006
End Date
November 1 2012
Last Update
October 9 2019
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637