Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Leiomyosarcoma
About this trial
This is an interventional treatment trial for Adult Angiosarcoma
Eligibility Criteria
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)
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.