Recruiting
Phase 1

Erlotinib

Sponsor:

Kansas City Veteran Affairs Medical Center

Code:

NCT00566800

Conditions

Esophageal Cancer

Precancerous Condition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

erlotinib hydrochloride

laboratory biomarker analysis

biopsy

Study Details

Brief 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.

Conditions

Esophageal Cancer

Precancerous Condition

Study ID

NCT00566800

Start date

Jul, 2007

Status verified date

Jan, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

erlotinib hydrochloride

laboratory biomarker analysis

biopsy

Primary outcome measure

  • Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Veterans Affairs Medical Center - Kansas City

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Joaquina C. Baranda, MD

816-861-4700 ext 6708joaquina.baranda2@med.va.gov

More Information

Sponsor

Kansas City Veteran Affairs Medical Center

Last update posted

Sep 17, 2013

Last verified

Jan, 2008

Keywords

  • esophageal cancer
  • Barrett esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Veteran Affairs Medical Center on 2013-09-17.