A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment

Exclusion Criteria

• •1. Subjects must not be pregnant, lactating, or refuse to use appropriate birth control
• •2. Subjects must not have an active infection requiring parenteral or oral antibiotics
• •3. Subjects must not have clinically significant cardiovascular or cerebrovascular disease, including:
• •Any history of:
• •* Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
• •* Ischemic bowel
• •* Hypertensive crisis or hypertensive encephalopathy Within the last 12 months
• •* Myocardial infarction
• •* Unstable angina
• •* New York Heart Association (NYHA) grade II or greater congestive heart failure
• •* Grade II or greater peripheral vascular disease
• •* DVT or PE Active at study entry
• •* Uncontrolled hypertension defined as SBP \> 150 or DBP \> 100
• •* Uncontrolled or clinically significant arrhythmia.
• •4. Subjects may not have locally recurrent or metastatic disease
• •5. Subjects may not require concurrent therapeutic anticoagulation. (NOTE: Prophylactic doses of coumadin to maintain patency of a vascular access device is allowed). In addition, subjects with a bleeding diathesis are excluded.
• •6. Subjects may not have had major surgery within 4 weeks of starting protocol therapy (NOTE: Placement of a vascular access device is not considered major surgery)
• •7. Subjects may not have received radiation therapy, chemotherapy or trastuzumab within the past 6 weeks (NOTE: Concurrent adjuvant hormonal therapy is allowed.)
• •8. Subjects may not have altered the physical therapy regimen for lymphedema within the past month
• •9. Subjects may not have an indwelling venous device in the ipsilateral arm
• •10. Subjects may not have bilateral lymphedema
• •11. Subjects may not have a non-healing wound, ulcer or bone fracture.
• •12. Subjects may not have a known hypersensitivity to any component of Bevacizumab