Erlotinib in Treating Patients With Barrett Esophagus

September 16, 2013 updated by: Kansas City Veteran Affairs Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Veterans Affairs Medical Center - Kansas City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride

Secondary Outcome Measures

Outcome Measure
Toxicity
Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
Validation of histologic scoring of Barrett dysplasia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Joaquina C. Baranda, MD, Kansas City Veteran Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Registration Dates

First Submitted

December 1, 2007

First Submitted That Met QC Criteria

December 1, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000576425
  • VAMCK-JB0027
  • GENENTECH-OSI3717s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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