Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer

DISEASE CHARACTERISTICS:

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

  • Diagnosis based on the primary lesion and/or lymph nodes
  • Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
• No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
• No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• ANC > 1,500/mm^3
• Platelet count > 100,000/mm^3
• Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed)
• Bilirubin ≤ 1.5 mg/dL
• AST, ALT, and AP ≤ 2.5 times upper limit of normal
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min

• None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:

  • Calcium < 7 mg/dL or > 12.5 mg/dL
  • Glucose < 40 mg/dL or > 250 mg/dL
  • Magnesium < 0.9 mg/dL or > 3 mg/dL
  • Potassium < 3 mmol/L or > 6 mmol/L
  • Sodium < 130 mmol/L or > 155 mmol/L
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
• No prior allergic reaction to study drugs

• No active cardiac disease, defined as any of the following:

  • Unstable angina
  • Uncontrolled hypertension
  • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
  • Uncontrolled arrhythmia
  • Congestive heart failure
  • Three or more heart-related hospitalizations within the past year
• No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
• No AIDS
• No pre-existing peripheral sensory neuropathy ≥ grade 2
• No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival

PRIOR CONCURRENT THERAPY:

• No prior systemic chemotherapy for this cancer

  • Prior systemic chemotherapy for a different cancer allowed
• No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
• No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
• At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
• No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)