Bevacizumab and Radiation Therapy for Sarcomas

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Bevacizumab

Criteria

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 central nervous system (CNS) disease

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

• Clinically significant cardiovascular disease, New York Heart Association (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