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Sponsored by: |
Kansas City Veteran Affairs Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00566800 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Precancerous/Nonmalignant Condition |
Drug: erlotinib hydrochloride Procedure: biopsy Procedure: laboratory biomarker analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia |
Estimated Enrollment: | 25 |
Study Start Date: | July 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy, and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy).
After completion of study treatment, patients are followed for 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Missouri | |
Veterans Affairs Medical Center - Kansas City | Recruiting |
Kansas City, Missouri, United States, 64128 | |
Contact: Joaquina C. Baranda, MD 816-861-4700 ext 6708 joaquina.baranda2@med.va.gov |
Principal Investigator: | Joaquina C. Baranda, MD | Kansas City Veteran Affairs Medical Center |
Study ID Numbers: | CDR0000576425, VAMCK-JB0027, GENENTECH-OSI3717s |
Study First Received: | December 1, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00566800 |
Health Authority: | Unspecified |
esophageal cancer Barrett esophagus |
Erlotinib Digestive System Neoplasms Precancerous Conditions Esophageal disorder Gastrointestinal Diseases Esophageal Neoplasms Digestive System Abnormalities |
Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases Congenital Abnormalities Esophageal neoplasm |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |