NCT00636298

Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy

Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab, cetuximab	Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly Bevacizumab - 10 mg/kg every 2 weeks

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2012-03-01
• First posted: 2008-03-14
• Last updated: 2013-11-19