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