A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

Inclusion Criteria:

- Primary soft tissue sarcoma (STS) or an isolated local recurrence of STS. Open
incisional biopsy or core biopsies should be performed within 8 weeks prior to
registration

- Tumor grade of intermediate or high grade

- Tumor must be located on the upper extremity, the lower extremity, trunk,
retroperitoneum, or pelvis

- Primary tumors must be > 5.0cm in maximal diameter and local recurrence can be any
size

- 18 years of age or older

- Zubrod performance status of 0-2

- Adequate organ and marrow function

Exclusion Criteria:

- Metastatic disease

- Pregnant or lactating women

- HIV positive patients

- Prior treatment with radiation, chemotherapy or biotherapy for this tumor

- History or evidence of CNS disease

- Serious, non-healing wound, ulcer, or bone fracture

- Clinically significant cardiovascular disease, NYHA Grade II or greater congestive
heart failure, serious cardiac arrhythmia requiring medication, or Grade II or
greater peripheral vascular disease within 1 year

- History of stroke within the past 6 months

- Major surgical procedure or significant traumatic injury within 28 days

- Current or recent (within 10 days) use of full-dose oral or parenteral anticoagulants
or thrombolytic agents.

- Presence of bleeding diathesis or coagulopathy

- Proteinuria at baseline or clinically significant impairment of renal function

- History of abdominal fistula, gastrointestinal perforation, or inta-abdominal abscess
within the past 6 months

- Documented history of uncontrolled seizures

- Grade 2 or greater sensory neuropathy based upon the NCI CTCAE, version 3.0

- Known history of deep vein thrombosis or pulmonary embolus

- Known hypercoagulable disorder

- History of hepatic cirrhosis or current hepatic dysfunction