Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Cetuximab; 50-60 Gy and 70 Gy
Intervention description: Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.; Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: SCC Head and Neck Cancer

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.
    

Eligibility 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.