Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Inclusion Criteria

• •Criteria:
• •Hemoglobin \>= 9 g/dL
• •Histologically or cytologically confirmed squamous cell carcinoma of the head and neck:
• •* Recurrent and/or metastatic disease
• •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques OR as \>= 10 mm with spiral CT scan
• •No known brain metastases
• •Life expectancy \>= 2 months
• •ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% (for patients in cohort A)
• •ECOG PS 2 or Karnofsky PS 60-70% (for patients in cohort B)
• •WBC \>= 3,000/mm\^3
• •Absolute neutrophil count \>= 1,500/mm\^3
• •Platelet count \>= 100,000/mm\^3
• •Calcium =\< 12.0 mg/dL
• •Bilirubin normal
• •AST and ALT =\< 2.5 times upper limit of normal
• •Creatinine normal OR creatinine clearance \>= 60 mL/min
• •QTc \< 500 msec
• •No New York Heart Association class III or IV heart failure:
• •* Patients with the following are eligible provided they have New York Heart Association class II cardiac function on baseline ECHO/MUGA:
• •* History of class II heart failure and asymptomatic on treatment
• •* Prior anthracycline exposure
• •* Prior central thoracic radiation that included the heart in the radiotherapy port
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No history of allergic reactions to compounds of similar chemical or biological composition to sunitinib malate
• •No history of serious ventricular arrhythmia (i.e., ventricular fibrillation or ventricular tachycardia \>= 3 beats in a row)
• •No history of other significant ECG abnormalities
• •No uncontrolled hypertension (defined as systolic blood pressure \[BP\] \>= 140 mm Hg or diastolic BP \>= 90 mm Hg)
• •No condition resulting in an inability to take oral medication, including any of the following:
• •* Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
• •* Active peptic ulcer disease
• •No gastrostomy, jejunostomy, or other forms of enteral tube-feeding modalities
• •No serious or nonhealing wound, ulcer, or bone fracture
• •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• •No cerebrovascular accident or transient ischemic attack within the past 12 months
• •No myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
• •No pulmonary embolism within the past 12 months
• •No pre-existing uncontrolled thyroid abnormality (i.e., inability to maintain thyroid function within the normal range with medication)
• •No uncontrolled intercurrent illness, including either of the following:
• •* Ongoing or active infection
• •* Psychiatric illness or social situation that would limit compliance with study requirement
• •No more than two prior regimens for recurrent or metastatic disease:
• •* Prior chemotherapy as part of initial curative intent therapy (e.g., neoadjuvant, adjuvant, or concurrent chemoradiotherapy) is allowed and will not count as prior therapy for recurrent or metastatic disease
• •At least 4 weeks since prior major surgery
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• •At least 4 weeks since prior radiotherapy
• •No prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or VEGF Trap)
• •No prior surgical procedure affecting absorption
• •At least 7 days since prior and no concurrent use of CYP3A4 inhibitors, including any of the following:
• •* Azole antifungals (e.g., ketoconazole, itraconazole)
• •* Verapamil
• •* Clarithromycin
• •* HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
• •* Erythromycin
• •* Delavirdine
• •* Diltiazem
• •At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• •* Rifampin
• •* Phenytoin
• •* Rifabutin
• •* Hypericum perforatum (St. John's wort)
• •* Carbamazepine
• •* Efavirenz
• •* Phenobarbital
• •* Tipranavir
• •No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin):
• •Concurrent dosing of =\< 2 mg of warfarin daily for prophylaxis of thrombosis is allowed; Concurrent low molecular weight heparin allowed provided prothrombin time INR is =\< 1.5
• •No other concurrent investigational agents
• •No concurrent agents with proarrhythmic potential, including any of the following:
• •* Terfenadine
• •* Quinidine
• •* Procainamide
• •* Disopyramide
• •* Sotalol
• •* Probucol
• •* Bepridil
• •* Haloperidol
• •* Risperidone
• •* Indapamide
• •* Flecainide
• •No other concurrent anticancer agents or therapies
• •No concurrent combination antiretroviral therapy for HIV-positive patients