Erlotinib in Treating Patients With Barrett Esophagus
Recruitment status was: Recruiting
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.
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia|
- Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride [ Designated as safety issue: No ]
- Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy [ Designated as safety issue: No ]
- Validation of histologic scoring of Barrett dysplasia [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566800
|United States, Missouri|
|Veterans Affairs Medical Center - Kansas City|
|Kansas City, Missouri, United States, 64128|
|Principal Investigator:||Joaquina C. Baranda, MD||Kansas City Veteran Affairs Medical Center|