Erlotinib in Treating Patients With Barrett Esophagus

Esophageal Cancer Clinical Trial

Official title:

Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00566800
• Other study ID #: CDR0000576425
• Secondary ID: VAMCK-JB0027GENE
• Status: Recruiting
• Phase: Phase 1
• First received: December 1, 2007
• Last updated: September 16, 2013
• Start date: July 2007

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

Primary

• 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.

Secondary

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• erlotinib hydrochloride

Other:
• laboratory biomarker analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride			No
Secondary	Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy			No
Secondary	Validation of histologic scoring of Barrett dysplasia			No
Secondary	Toxicity			Yes