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

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.