Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients Who Have Undergone Surgery for Advanced Hypopharyngeal Cancer, Oropharyngeal Cancer, Laryngeal Cancer, or Oral Cavity Cancer at High Risk of Recurrence

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, tongue cancer Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed primary squamous cell carcinoma of the hypopharynx, oropharynx, larynx, or oral cavity

  • Stage pT1-2 pN+ or pT3-4 any pN (stage III-IVB) disease
  • No distant metastases
  • No recurrent disease

• Resectable disease

  • Has undergone surgical resection of carcinoma

    • p16 immunohistochemistry assay performed on tissue sections taken during the surgical procedure
    • No laser surgery

• Potentially at high-risk of locoregional recurrence, defined as fulfilling ≥ 1 of the following criteria:

  • Close surgical margins (i.e., margins 1 mm to < 5 mm)
  • R1-resection (< 1 mm) (R2 resection is considered as not eligible)
  • Extracapsular nodal extension
• No nasopharynx, nasal cavity, or paranasal sinuses carcinomas

PATIENT CHARACTERISTICS:

• WHO or ECOG performance status 0-1
• Absolute neutrophils ≥ 1.5 x 10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin ≥ 10.0 g/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• AST< 3 times ULN
• Alkaline phosphatase < 3 times ULN
• Calculated creatinine clearance ≥ 60 mL/min
• Calcium ≤ 11.5 mg/dL or 2.9 mmol/L
• Magnesium ≥ 1.2 mg/dL or 0.5 mmol/L
• Fertile patients must use effective contraception methods during the study and for 6 months after the last treatment dose
• Not pregnant or nursing
• No known allergic or hypersensitivity reaction to any of the components of the study treatment

• No other concurrent serious illnesses or medical conditions, including any of the following:

  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Unstable cardiac disease despite treatment
  • NYHA class III-IV congestive heart failure
  • Clinically significant abnormal ECG or LVEF below the institutional lower limit of normal
  • Known HIV infection or other conditions of persistent immunodeficiency
  • Significant neurologic or psychiatric disorders
  • Active uncontrolled infection
  • Active disseminated intravascular coagulation
  • Symptomatic peripheral neuropathy (CTCAE 4.0 "peripheral sensory neuropathy and paresthesia") ≥ grade 2 or ototoxicity (CTCAE 4.0 "hearing impaired") ≥ grade 2, unless due to trauma or mechanical impairment due to tumor mass
  • Other serious underlying medical conditions that could impair the ability of the patient to participate in the study

• No other malignancy within the past 5 years other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix

  • Patients who are disease-free for > 5 years allowed
• No known drug abuse
• No psychological, familial, sociological (e.g., severe alcohol addiction expected to hamper protocol compliance), or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for carcinoma of the head and neck
• No prior radiotherapy to the head and neck region
• No prior exposure to EGFR pathway-targeting therapy
• No participation in another interventional clinical trial within the past 30 days
• No concurrent granulocyte colony-stimulating factor (G-CSF) or erythropoietin
• No other concurrent investigational drugs and/or anticancer treatment