Radiation Therapy with Cisplatin or Docetaxel and Cetuximab in Treating Patients with Stage III-IVB Head and Neck Cancer

Inclusion Criteria

• Pathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx with no evidence of distant metastasis; biopsy sampling of primary tumor with pathology report documenting diagnostic tissue type is required
• Patients must have stage III, IVa or IVb disease as determined by imaging studies and complete head and neck exam; staging evaluation should be in accordance with the American Joint Committee on Cancer Staging Manual, 7th edition
• Patients with oropharyngeal squamous cell carcinoma may have p16(+) or p16(-) disease; in these patients, p16 status must be known prior to randomization; assessment of p16 status may occur locally or centrally; note: the definition of p16(+) disease is diffuse nuclear and cytoplasmic staining in >= 70% of tumor cells
• Patients must be untreated with curative-intent surgery for current diagnosis of stage III, IVa, or IVb disease; diagnostic biopsy of primary tumor and/or nodal sites is permitted. * Diagnostic simple tonsillectomy is permitted, provided patient has Response Evaluation Criteria in Solid Tumors (RECIST)-measurable residual tumor and/or nodal disease * Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy/radiotherapy), and has not recurred
• Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1-2, N0, M0 resected differentiated thyroid carcinoma, who are eligible
• No prior systemic treatment (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer * Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed * Patients must be untreated with radiation above the clavicles * Patients with a history of curatively-treated non-HNSCC malignancy must be disease-free for at least 2 years except for carcinoma-in-situ of cervix, non-melanomatous skin cancer, or T1-2, N0, M0 resected differentiated thyroid carcinoma
• Diagnostic primary tumor tissue must be available for ERCC1 staining
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have measurable disease according to RECIST 1.1
• Absolute neutrophil count (ANC) > 1500/mm^3 (within 4 weeks of registration)
• Hemoglobin (Hb) > 8.0 g/dL (within 4 weeks of registration)
• Platelet count (PLT) > 100,000/mm^3 (within 4 weeks of registration)
• Creatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockcroft-Gault formula (within 4 weeks of registration)
• Total bilirubin < 2 mg/dL (within 4 weeks of registration)
• AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 3 times upper limit of normal (ULN) (within 4 weeks of registration)
• The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin
• The following metabolic laboratory values will exclude patients from study enrollment: * Calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels * Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator’s discretion * Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels * Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels
• No prior severe infusion reaction to a monoclonal antibody
• Written informed consent must be obtained from all patients prior to beginning therapy; patients should have the ability to understand and the willingness to sign a written informed consent document
• Informed consent must be obtained from all patients prior to beginning therapy, including consent for mandatory tissue submission for ERCC1 staining (and p16 staining if not locally conducted); patients should have the ability to understand and the willingness to sign a written informed consent document
• No unstable angina or myocardial infarction within the prior 6 months; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no cerebrovascular ischemia or stroke within the past 6 months
• No uncontrolled intercurrent illness including active infection, uncontrolled diabetes, uncontrolled hypertension, or uncontrolled psychiatric illness which in the investigator’s opinion would limit compliance with study requirements or compromise patient safety
• Women must not be pregnant or breast feeding; pregnant women are excluded from this study
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately; all females of childbearing potential must have a blood test or urine study within 14 days of registration to rule out pregnancy
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated; note: HIV testing is not required for entry into this protocol
• Patients may not be receiving any other anti-neoplastic investigational agents