Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

Inclusion Criteria

• •Histologically or cytologically confirmed sarcoma, including any of the following neoplastic subtypes:
• •* Giant hemangioma
• •* Angiosarcoma (including epithelioid hemangioendothelioma)
• •* Malignant peripheral nerve sheath tumor
• •* Leiomyosarcoma (closed to accrual as of 11/29/06)
• •* High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous histiocytoma \[including myxofibrosarcoma\]) (closed to accrual as of 11/29/06)
• •* Synovial sarcoma (closed to accrual as of 11/29/06)
• •* Carcinosarcoma (closed to accrual as of 11/29/06)
• •Metastatic, locally advanced, or locally recurrent disease
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• •* Lesions in a previously irradiated area may be considered measurable provided there is evidence of subsequent disease progression that cannot be attributed to necrosis or bleeding
• •No gastrointestinal stromal tumor
• •No known brain metastases
• •Performance status - ECOG 0-2
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •No evidence of bleeding diathesis
• •Bilirubin ≤ 1.5 mg/dL
• •INR ≤ 1.5
• •AST and ALT ≤ 2.5 times upper limit of normal
• •Creatinine ≤ 1.5 mg/dL
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •No uncontrolled hypertension
• •No history of allergic reaction to compounds of similar chemical or biologic composition to sorafenib
• •No known HIV positivity
• •No active or ongoing infection
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No psychiatric illness or social situation that would preclude study compliance
• •No swallowing dysfunction that would preclude the swallowing of tablets
• •Other malignancies allowed provided sarcoma is the primary disease requiring treatment
• •No other uncontrolled illness
• •No more than 1 prior chemotherapy regimen for recurrent or metastatic disease (≤ 3 regimens for angiosarcoma or malignant peripheral nerve sheath tumor)
• •* Adjuvant chemotherapy completed \> 1 year prior to study entry is not considered a line of prior treatment
• •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• •At least 3 weeks since prior radiotherapy
• •Recovered from prior antitumor therapy
• •* Alopecia allowed
• •No prior sorafenib
• •No prior small molecule inhibitors of MAPK signaling intermediates
• •No concurrent therapeutic anticoagulation
• •* Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial devices allowed provided requirements for PT, INR, or PTT requirements are met
• •No other concurrent investigational agents
• •No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
• •No concurrent rifampin or Hypericum perforatum (St. John's wort)