Enzalutamide in Treating Patients with Androgen Receptor Positive Locally Advanced or Metastatic Salivary Cancers That Cannot Be Removed by Surgery

Inclusion Criteria

• Histologically proven diagnosis of salivary cancer by central pathology review
• AR expression detected by immunohistochemistry by central review
• Measurable disease
• Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease
• Any number of prior lines of therapy
• No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration
• No prior therapy with enzalutamide (previous chemotherapy and/or other AR-targeted approaches is allowed)
• Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months * For women of childbearing potential only, a negative pregnancy test done =< 5 days prior to registration is required
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• No history of the following * Prior brain metastases * Leptomeningeal disease * Seizures * Class 3 or 4 congestive heart failure * Uncontrolled hypertension (systolic blood pressure [BP] > 170 mmHg or diastolic BP > 105 mmHg) despite optimal medical management * Major surgery =< 4 weeks of registration
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/min
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 upper limit of normal (ULN)
• Chronic concomitant treatment with strong cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration
• Chronic concomitant treatment with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors is not allowed; patients must discontinue the drug >= 14 days prior to registration