Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.
Loco-regional Esophageal Cancer
Radiation: Radiation Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma|
- The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To assess the toxicity of this regimen. [ Time Frame: Every three weeks for one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.