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Sponsors and Collaborators: |
University of Chicago Bayer |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00619242 |
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
Condition | Intervention |
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Esophageal Cancer |
Drug: sorafenib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia |
Estimated Enrollment: | 15 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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sorafenib: Experimental |
Drug: sorafenib
2 tablets with water by mouth twice a day for two weeks.
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To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with the following other concurrent illness are excluded:
Patients must have adequate organ and marrow function as defined below:
Exclusion Criteria:
A patient will be withdrawn from the study if any of the following events occur while on therapy:
Contact: Ezra Cohen, MD | 773/702-4137 | ecohen@medicine.bsd.uchicago.edu |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Ezra Cohen, MD 773-702-4137 ecohen@medicine.bsd.uchicago.edu | |
Principal Investigator: Ezra Cohen, MD |
Principal Investigator: | Ezra Cohen, MD | University of Chicago |
Responsible Party: | University of Chicago ( Ezra Cohen, MD ) |
Study ID Numbers: | 14374B |
Study First Received: | February 6, 2008 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00619242 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Esophageal cancer |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Protein Kinase Inhibitors Digestive System Abnormalities Digestive System Diseases Esophageal Disorder |
Barrett Syndrome Head and Neck Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases Congenital Abnormalities Sorafenib |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Neoplasms |
Digestive System Abnormalities Digestive System Diseases Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases Sorafenib |