Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate

Inclusion Criteria

• •Histologically confirmed gastrointestinal stromal tumor
• •* Not amenable to curative surgery
• •Kit-expressing tumor
• •Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
• •* Only site of measurable disease must be outside of previously irradiated area
• •No known brain metastases
• •Performance status - ECOG 0-2
• •More than 3 months
• •Absolute neutrophil count \> 1,500/mm\^3
• •Platelet count \> 100,000/mm\^3
• •Bilirubin normal
• •AST and ALT \< 2.5 times upper limit of normal
• •Creatinine ≤ 1.5 mg/dL
• •Creatinine clearance \> 60 mL/min
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •No uncontrolled hypertension
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No history of allergic reaction 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 uncontrolled illness
• •No evidence of bowel perforation or obstruction
• •No prior angiogenesis inhibitors
• •No immunotherapy after the last dose of imatinib mesylate or sunitinib malate
• •No chemotherapy or chemoembolization therapy after the last dose of imatinib mesylate or sunitinib malate
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy and recovered
• •At least 14 days since prior imatinib mesylate or sunitinib malate
• •No prior sorafenib
• •No prior inhibitors of MAPK-signaling intermediates
• •No other investigational agent after the last dose of imatinib mesylate or sunitinib malate
• •Concurrent anticoagulation therapy with warfarin allowed provided the following criteria are met:
• •* On a therapeutic stable warfarin dose
• •* INR ≤3
• •* No active bleeding or pathologic condition that confers a high risk of bleeding
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No concurrent administration of any of the following:
• •* Enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital)
• •* Hypericum perforatum (St. John's wort)
• •* Rifampin
• •No other concurrent anticancer agents or therapies