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

Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities

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.

Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.

Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.

Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.

Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.

Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.

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.