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

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