Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

Stopped early · Phase 2

Conditions studied: Head and Neck Cancer

In brief

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

Key facts

Study ID

NCT00904345

Run by

University of Michigan Rogel Cancer Center

People needed

23

Starts

2009-04-01

Expected to finish

2020-12-01

Last updated by the study team

2021-02-24

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
• Patients will be limited to:
• ≥ 70 years of age, OR
• with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
• KPS ≤ 80, OR
• Creatinine clearance < 30 cc/min
• Laboratory criteria:
• WBC > 3500/ul
• Granulocyte > 1500/ul
• Platelet count > 100,000/ul
• Total Bilirubin < 1.5 X ULN
• AST and ALT < 2.5 X ULN
• Patients must give documented informed consent to participate in this study.

You may not qualify if…

• Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
• Prior head and neck radiation or chemotherapy.
• Documented evidence of distant metastases.
• Patients with nasopharyngeal carcinoma.
• Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
• Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
• Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
• Patients residing in prison.

Where it is running

• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Michigan Veterans Administration Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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