S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
• •* Angiosarcoma, cutaneous or visceral
• •* Malignant hemangiosarcoma
• •* Malignant hemangiopericytoma
• •* Grade 3-4 leiomyosarcoma
• •* Grade 3-4 liposarcoma
• •Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
• •Measurable disease by x-ray, scans, or physical examination
• •Archived paraffin-embedded tumor sections available
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Zubrod 0-1
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC ≥ 3,000/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hepatic
• •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
• •Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
• •PT, PTT, and INR normal
• •Renal
• •Creatinine normal OR
• •Creatinine clearance ≥ 60 mL/min
• •Cardiovascular
• •No history of thromboembolic disease
• •No uncontrolled hypertension
• •Other
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •Able to swallow oral medication
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
• •Prior adjuvant chemotherapy allowed
• •No more than 1 prior chemotherapy regimen for metastatic disease
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •At least 28 days since prior radiotherapy and recovered
• •* Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy
• •Surgery
• •At least 28 days since prior major surgery and recovered
• •Other
• •No prior sorafenib
• •No prior inhibitor of VEGFR or MAPK pathway
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent investigational agents
• •No concurrent therapeutic anticoagulation
• •No concurrent administration of any of the following medications:
• •* Rifampin
• •* Hypericum perforatum (St. John's wort)
• •* Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
• •* Phenytoin
• •* Carbamazepine
• •* Phenobarbital