Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy
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|ClinicalTrials.gov Identifier: NCT00636298|
Recruitment Status : Withdrawn (lack of funding)
First Posted : March 14, 2008
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Carcinoma||Drug: Bevacizumab, cetuximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||March 2012|
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
- Progression-free survival [ Time Frame: Every 3 months ]
- Response rate [ Time Frame: Every 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636298
|Principal Investigator:||Nabil Saba, MD||Emory University Winship Cancer Institute|