Sorafenib and Dacarbazine in Soft Tissue Sarcoma

Exclusion Criteria

• •Prior therapy with dacarbazine, sorafenib or other antiangiogenic agents.
• •Chemotherapy within 3 weeks or radiotherapy within 2 weeks of first day of protocol therapy.
• •More than two prior chemotherapy regimens.
• •Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• •Pregnancy or nursing.
• •Social situation or psychiatric illness that would limit compliance with study requirements.
• •Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• •Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg for more than 24 hours, despite optimal medical management.
• •Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• •Active clinically serious infection \> CTCAE Grade 2.
• •Thrombotic or embolic events such as a cerebrovascular accident, transient ischemic attack or myocardial infarction within the past 6 months, or deep venous thrombosis or pulmonary embolism within two months.
• •Pulmonary hemorrhage/bleeding event \> or = to CTCAE Grade 2 within 4 weeks of first dose of study drug.
• •Any other hemorrhage/bleeding event \> or = to CTCAE Grade 3 within 4 weeks of first dose of study drug.
• •Serious non-healing wound, ulcer, or bone fracture.
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Any history of grade 4 thrombocytopenia (Plt \<25,000), Grade 3 thrombocytopenia (Plt \<50,000, \>25,000) lasting 7 days or longer, or history of platelet transfusions for chemotherapy induced thrombocytopenia
• •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• •Use of St. John's Wort or rifampin (rifampicin).
• •Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• •Any condition that impairs patient's ability to swallow pills.
• •Any malabsorption problem that in the opinion of the investigator would interfere with the patients ability to tolerate oral sorafenib.