Afatinib Dimaleate and Cetuximab as Second-Line Treatment in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck that is metastatic or recurrent and not treatable with curative intent
• Previous treatment with platinum-based regimen or immune checkpoint inhibitor therapy or both in the R/M (recurrent/metastatic) setting 2-week washout period prior to treatment start will be required
• Patients who have experienced progression of disease within 6 months following completion of a platinum-based chemoradiation in the definitive or adjuvant setting will be permitted
• Prior cetuximab permitted if it was given as part of multi-modality therapy for initial treatment of locally advanced disease but not for recurrent/metastatic disease
• Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; baseline measurements and evaluations must be obtained within < 4 weeks of enrollment; disease in previously irradiated sites is considered measurable if there has been unequivocal disease progression or biopsy-proven residual carcinoma following radiation therapy
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Hemoglobin >= 8 g/dl
• Absolute neutrophil count (ANC) >= 1000/mm^3
• Platelet count >= 75,000/mm^3
• Estimated creatinine clearance > 45 ml/min
• Total bilirubin =< 1.5 times upper limit of (institutional/central) normal (patients with Gilbert’s syndrome total bilirubin must be =< 4 times institutional upper limit of normal)
• Aspartate amino transferase (AST) or alanine amino transferase (ALT) =< three times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases =< five times ULN)
• Ability to understand and the willingness to sign a written informed consent that is consistent with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines
• Negative urine or serum pregnancy test for women of childbearing potential
• A second eligibility review will always be provided by a Head and Neck Research Team associated for the New Haven Campus and a third review will be provided by the principal investigator (PI)

Exclusion Criteria

• Prior erlotinib, gefitinib or lapatinib therapy or prior exposure to any investigational EGFR or panErbB reversible or irreversible inhibitor or any prior panitumumab or investigational EGFR-directed monoclonal antibody. Cetuximab is permitted if used for locally advanced disease, as long as no disease progression within 6 months. Cetuximab use is not permitted for recurrent/metastatic disease
• Known hypersensitivity to afatinib or its excipients
• Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly prior to study entry, for the duration of study participation and for at least 4 weeks after treatment has ended
• Pregnant or nursing women
• Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
• Concomitant malignancies at other sites that are being actively treated with systemic therapy
• Requiring treatment with any of the prohibited concomitant medications that cannot be stopped for the duration of trial participation
• Clinically significant interstitial lung disease
• Known history of untreated viral hepatitis or human immunodeficiency virus (HIV)
• Patients with parenchymal brain metastases are not eligible, unless they have completed local therapy
• Leptomeningeal carcinomatosis