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Tyrosine Kinase Inhibitor

Erlotinib for Barrett's Esophagus

Phase 1

Waitlist Available

Led By Joaquina C. Baranda, MD

Research Sponsored by Kansas City Veteran Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Barrett esophagus with high-grade dysplasia

Able to swallow tablets or dissolved tablets

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying if erlotinib can prevent esophageal cancer in patients with Barrett esophagus by blocking some of the enzymes needed for cell growth.

Who is the study for?

This trial is for adults with Barrett esophagus, a condition that can lead to esophageal cancer. Participants must not be pregnant or nursing and should use effective contraception. They cannot have invasive esophageal carcinoma, known hypersensitivity to erlotinib hydrochloride, uncontrolled conditions, or other malignancies. Blood counts and liver function tests must meet specific criteria.Check my eligibility

What is being tested?

The trial is testing Erlotinib's effectiveness in preventing the development of esophageal cancer in patients with Barrett's Esophagus by inhibiting enzymes necessary for cell growth. This phase II study aims to see if Erlotinib can stop cancer from forming.See study design

What are the potential side effects?

Erlotinib may cause side effects such as rash, diarrhea, appetite loss, fatigue, coughing or shortness of breath; however detailed side effect profile will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a severe form of Barrett's esophagus.

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I can swallow pills or dissolved tablets.

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I have refused surgery or other treatments for a severe precancerous condition.

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I have not experienced symptoms like weight loss or vomiting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy

Toxicity

Validation of histologic scoring of Barrett dysplasia

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kansas City Veteran Affairs Medical CenterLead Sponsor

23 Previous Clinical Trials

8,543 Total Patients Enrolled

Joaquina C. Baranda, MDPrincipal InvestigatorKansas City Veteran Affairs Medical Center

Media Library

Erlotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00566800 — Phase 1

Esophageal Cancer Research Study Groups:

Esophageal Cancer Clinical Trial 2023: Erlotinib Highlights & Side Effects. Trial Name: NCT00566800 — Phase 1

Erlotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00566800 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment still available for participants?

"The clinicaltrials.gov website lists this trial as not currently recruiting any new participants, having first been posted on July 1st 2007 and last updated six years ago in 2013. However, there are approximately 426 other trials actively seeking enrollees at the moment."

Answered by AI

Are there any dangers associated with utilizing this remedy?

"This therapy has only had limited testing, so its safety was rated a 1. Consequently, there is still uncertainty surrounding the efficacy of this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Erlotinib in Treating Patients With Barrett Esophagus

2007. "Erlotinib in Treating Patients With Barrett Esophagus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00566800.

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