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Sponsors and Collaborators: |
Emory University Genentech |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00636298 |
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.
Condition | Intervention | Phase |
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Esophageal Carcinoma |
Drug: Bevacizumab, cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy |
Estimated Enrollment: | 20 |
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) |
Arms | Assigned Interventions |
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A: Experimental
Single arm treatment with combination of cetuximab and bevacizumab
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal bone marrow and other organ function or defined below:
Platelet counts, > 100, 00/μL
Exclusion Criteria:
I. Disease-specific Exclusions
II. General Medical Exclusions
Subjects meeting any of the following criteria are ineligible for study entry:
III. Bevacizumab-Specific Exclusions
Proteinuria at screening as demonstrated by either
Responsible Party: | Emory ( Nabil Saba, MD ) |
Study ID Numbers: | 6037 |
Study First Received: | March 11, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00636298 History of Changes |
Health Authority: | United States: Institutional Review Board |
esophageal carcinoma cancer of the esophagus locally advanced or metastatic esophageal cancer |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Cetuximab Esophageal Cancer Bevacizumab Angiogenesis Inhibitors |
Carcinoma Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Growth Substances Esophageal Neoplasms Physiological Effects of Drugs Cetuximab Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Esophageal Diseases Neoplasms, Glandular and Epithelial |