Erlotinib in Treating Patients With Barrett Esophagus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00566800
First received: December 1, 2007
Last updated: September 16, 2013
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Precancerous Condition
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Procedure: biopsy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566800

Locations
United States, Missouri
Veterans Affairs Medical Center - Kansas City Recruiting
Kansas City, Missouri, United States, 64128
Contact: Joaquina C. Baranda, MD    816-861-4700 ext 6708    joaquina.baranda2@med.va.gov   
Sponsors and Collaborators
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Joaquina C. Baranda, MD Kansas City Veteran Affairs Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00566800     History of Changes
Other Study ID Numbers: CDR0000576425, VAMCK-JB0027, GENENTECH-OSI3717s
Study First Received: December 1, 2007
Last Updated: September 16, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
esophageal cancer
Barrett esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Barrett Esophagus
Precancerous Conditions
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Abnormalities
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014