Phase II Trial of BAY 43-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas

Histologic evidence of soft tissue sarcoma with one of the following histologies: angiosarcoma, cutaneous or visceral; malignant hemangiosarcoma; malignant hemangiopericytoma; Grade 3-4 leiomyosarcoma; Grade 3-4 liposarcoma. Malignant SFT are eligible. Unresectable disease or metastatic disease or recurrent disease by radiographic examination. (For pts with cutaneous angiosarcoma, visual assessment is sufficient.) Must have measurable disease, which must have been assessed within 28 days prior to reg. Non-measurable disease must have been assessed within 42 days prior to reg. Must submit archived tissue and slides. Must seek additional consent to submit fresh frozen tissue. Up to one prior chemo regimen allowed beyond the adjuvant setting (at least 28 days [42 for BCNU or mitomycin C] must have elapsed and must have recovered from all toxicities). No prior BAY 43-9006 or any inhibitor of VEGFR or the MAPK pathway. Prior RT allowed if there is progressive dz within or measurable dz outside radiation field (at least 28 days must have elapsed and must have recovered from all toxicities). Prior surgery allowed (at least 28 days must have elapsed and must have recovered from all toxicities). Within 28 days prior to reg: Leukocytes >/= 3,000/mcL; ANC >/= 1,500/mcL; Platelets >/= 100,000/mcL; Total bilirubin </= IULN; SGOT/SGPT </= 2.5 x IULN (</= 5 x IULN if liver mets); Serum creatinine </= IULN OR creatinine clearance >/= 60 mL/min; PT, INR and PTT </= IULN. Zubrod Performance Status 0-1. Age >/= 18 years. Must be able to swallow oral meds. Must not be receiving any other investigational agents. No history of thromboembolic disease. No therapeutic anticoagulation. No uncontrolled hypertension. No cytochrome 450 enzyme-inducing antiepileptic drugs, rifampin or St. Johns Wort. No known brain metastases. No HIV-positive patients receiving combination antiretroviral therapy. No pregnant or nursing patients.