Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy
The purpose of this study is to test the drug bevacizumab in combination with cetuximab. Because this combination has not been tested in cancer patients before, results will be analyzed to see what effects the combination of bevacizumab with cetuximab has on esophageal cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy|
- Progression-free survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Single arm treatment with combination of cetuximab and bevacizumab
Drug: Bevacizumab, cetuximab
Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly
Bevacizumab - 10 mg/kg every 2 weeks
Cancer of the esophagus often has a poor outcome since many patients have advanced disease when they are diagnosed. The average survival rate after five years has increased from 4% in the 1970s to around 14% currently.
Surgery to remove the tumor or treatment with radiotherapy alone has led to disappointing results for patients. Chemotherapy has some activity in patients with advanced disease, although responses are usually short. New strategies are trying to combine these three treatment approaches to improve survival for these patients.
This study will test the combination of cetuximab and bevacizumab in patients with locally advanced esophageal cancer. This is a group of patients with usually poor outcomes from treatment with surgery, radiotherapy or chemotherapy alone. Scientifically, this study will help assess the value in combining these two different types of drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636298
|Principal Investigator:||Nabil Saba, MD||Emory University Winship Cancer Institute|