Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

Criteria: Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or combined with radiotherapy) No symptomatic bulky disease that would impair the airway or impede swallowing (for patients with ECOG performance status 2) No known brain metastases Measurable or evaluable disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan Measurable disease not in a previously irradiated field Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible provided disease has been stable for the past 6 months Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy more than 8 weeks Absolute neutrophil count >= 1,250/mm3 Platelet count >= 100,000/mm3 No evidence of bleeding diathesis Bilirubin =< 1.5 times upper limit of normal (ULN) PTT =< 1.5 times ULN Creatinine =< 1.5 times ULN No myocardial infarction within the past 6 months No New York Heart Association class III or IV cardiac disease No symptomatic congestive heart failure No unstable angina pectoris No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg OR diastolic BP > 100 mm Hg) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to swallow oral medication No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No other uncontrolled illness No more than 2 prior systemic cytotoxic chemotherapy regimens (combined modality systemic cytoxic chemotherapy is considered 1 prior cytotoxic regimen) At least 7 days since prior chemotherapy and recovered At least 7 days since prior radiotherapy and recovered No prior sorafenib or other inhibitors of MAP kinase signaling intermediates No prior cancer treatment that would preclude study participation No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) No concurrent Hypericum perforatum (St. John's wort) or rifampin No concurrent therapeutic anticoagulation (concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided requirements for INR and PTT are met) No other concurrent anticancer therapy Histologically confirmed anaplastic* thyroid cancer Not amenable to definitive curative surgery or radiotherapy [Note: *Papillary, follicular, or other histologies that are mixed or identified in a diagnostic tissue sample are allowed provided a high-grade undifferentiated anaplastic component is present ] No cardiac arrhythmia AST and ALT =< 3.5 times ULN INR < 2.0