Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma
Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this
study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then
bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized
monoclonal antibody (a type of protein that is normally made by the immune system to help
defend the body from infection and cancer) produced by Genentech, Inc. using recombinant
DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic
colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the
treatment of esophageal cancer and has not been approved by the FDA for the treatment of
esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth
factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal
blood vessel formation. It is present in a wide variety of normal tissues, but is produced
in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the
growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory
animals, bevacizumab inhibits the growth of several different types of human cancer cells,
including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your
doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease
the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
5 years
No
Susan Urba, MD
Principal Investigator
University of Michigan Cancer Center
United States: Institutional Review Board
UMCC 2006.117
NCT00570531
June 2007
June 2015
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