Afatinib Dimaleate and Radiation Therapy with or without Docetaxel in Treating Patients with Head and Neck Cancer Previously Treated with Surgery

Inclusion Criteria

• Stage III-IV SCCHN and select stage II participants (T2N0 oral cavity cancer with > 5 mm depth invasion)
• Histologically proven diagnosis of squamous cell carcinoma of the head and neck, including variants such as spindle cell carcinoma, verrucous carcinoma, carcinoma not otherwise specified (NOS), etc.
• The pathology from the primary surgery must be reviewed and finalized at either Dana-Farber Cancer Institute/Brigham & Women's Hospital or the pathology department at any participating institutions
• Status post gross total resection with curative intent
• No prior anti-epidermal growth factor (EGF) or anti-human epidermal growth factor receptor 2 (HER2) therapy
• No prior radiation therapy to the head and neck; prior radiation therapy to body sites other than the head and neck are permitted provided that the treating radiation oncologist determines that there is no overlap between the head and neck radiation plan and the prior radiation fields
• Eastern Cooperative Oncology Group (ECOG) status 0-2 within 1 month prior to registration
• Primary tumor site: oral cavity, oropharynx, larynx, hypopharynx
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 8.0 g/dL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Alkaline phosphatase =< 2.5 x institutional upper limit of normal
• Creatinine =< institutional upper limit or creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels above institutional normal
• Participants' disease must be defined as either high-risk or intermediate risk: * Definition of high-risk: any of the following high-risk features: ** Positive margins (defined as tumor at ink) ** Extracapsular extension of lymph node ** Gross T4a or T4b primary tumor ** Any lymph node >= 6 cm (N3) * Definition of intermediate-risk: absence of any high-risk features AND any one of the following intermediate risk features: ** Close margins (defined as < 5 mm) ** T3 or microscopic T4 tumor ** Two or more positive lymph nodes involved with squamous cell carcinoma ** Single lymph node > 3 cm and < 6 cm ** Perineural invasion ** Lymphovascular invasion ** Level IV or level V involvement of oral cavity or oropharyngeal tumors ** T2 oral cavity tumor with > 5 mm depth of invasion
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Chest imaging =< 3 months of enrollment, including computed tomography (CT)-scan or chest x-ray
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Participants who have had prior radiation therapy to the head and neck
• Participants who have had prior anti-EGF or anti-HER2 therapy or cancer-directed chemotherapy
• Distant metastases
• Participants may not be receiving any other study agents
• History of interstitial lung disease
• Symptomatic peripheral neuropathy >= grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (for participants receiving docetaxel only)
• No active malignancy; participants that received curative treatment for a prior cancer are eligible provided there is no prior head and neck radiation and no prior chemotherapy or anti-EGF or anti-HER2 therapy as above
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to afatinib or docetaxel
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because afatinib is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with afatinib, breastfeeding should be discontinued if the mother is treated with afatinib; these potential risks may also apply to other agents used in this study
• Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with afatinib; in addition, these individuals are at increased risk of lethal infections when treated with marrow suppressive therapy; HIV testing is not required for inclusion in this study