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Erlotinib in Treating Patients With Barrett Esophagus

16. september 2013 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

Fase

Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Missouri
  - Kansas City, Missouri, Forente stater, 64128
    - Rekruttering
    - Veterans Affairs Medical Center - Kansas City
    - Ta kontakt med:
      
      Joaquina C. Baranda, MD
      
      Telefonnummer: 816-861-4700 ext 6708
      
      E-post: joaquina.baranda2@med.va.gov

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kansas City Veteran Affairs Medical Center

Etterforskere

Hovedetterforsker: Joaquina C. Baranda, MD, Kansas City Veteran Affairs Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2007

Datoer for studieregistrering

Først innsendt

1. desember 2007

Først innsendt som oppfylte QC-kriteriene