Clinical trial · Interventional
Erlotinib in Treating Patients With Barrett Esophagus
Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
NCT00566800CI-TRIAL-00012145unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
Secondary outcomes (3)
- measure
- Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
- measure
- Validation of histologic scoring of Barrett dysplasia
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Barrett esophagus with high-grade dysplasia * Refused surgery or other localized therapy for high-grade dysplasia * No invasive esophageal carcinoma PATIENT CHARACTERISTICS: * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Bilirubin normal * AST and ALT \< 3 times upper limit of normal (ULN) * Alkaline phosphatase \< 3 times ULN * No uncontrolled medical condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment * Able to swallow tablets or dissolved tablets * No known hypersensitivity to erlotinib hydrochloride * No symptoms suggestive of malignancy (e.g., weight loss or vomiting) * No history of other malignancies * No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior exposure to erlotinib hydrochloride * No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy * No concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.