Erlotinib in Treating Patients With Barrett Esophagus
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|ClinicalTrials.gov Identifier: NCT00566800|
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : December 4, 2007
Last Update Posted : September 17, 2013
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 or disease||Intervention/treatment||Phase|
|Esophageal Cancer Precancerous Condition||Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Procedure: biopsy||Phase 1|
- To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can cause histologic regression of Barrett esophagus in patients at high risk of developing esophageal cancer associated with high-grade dysplasia.
- To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus with high-grade dysplasia.
- To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade dysplasia.
- To validate the histologic scoring of Barrett dysplasia developed by our group.
- To evaluate toxicities associated with the use of erlotinib hydrochloride in patients with Barrett esophagus associated with high-grade dysplasia.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Masking:||None (Open Label)|
|Official Title:||Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia|
|Study Start Date :||July 2007|
- Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
- Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
- Validation of histologic scoring of Barrett dysplasia
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): NCT00566800
|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 firstname.lastname@example.org|
|Principal Investigator:||Joaquina C. Baranda, MD||Kansas City Veteran Affairs Medical Center|