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Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor

21 oktober 2014 bijgewerkt door: Dong Shin, Emory University

Phase I/II Study of Chemoprevention With Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva) and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Premalignant Lesions of Head and Neck of Former Smokers

Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiving the study medications.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may tell how the drug works, before, and after receiving the study medications.

Approximately 61 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital in Atlanta, Georgia.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

17

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory University Winship Cancer Institute

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Participants must have premalignant lesions.
  • Lesion sites include oral cavity, oropharynx, and larynx.
  • Must have at least a >20 pack-year history of smoking.
  • Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
  • Participants must be 18 years of age or older.
  • No contraindications for laryngoscopy and biopsy.
  • Adequate liver function.
  • Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
  • Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
  • Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
  • Must be able to swallow the oral dose of erlotinib and celecoxib.
  • Participants must be disease free.
  • Final eligibility will be determined by the health professionals conducting the trial.

Exclusion Criteria:

  • Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
  • History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
  • Pregnant or breast feeding.
  • Not practicing adequate contraception if the participants are of child bearing potential.
  • Female patients who have a positive pregnancy test.
  • History or recent myocardial infarction.
  • Hypertension not adequately controlled by medication.
  • Documented history of coagulopathy.
  • Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
  • Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
  • Documented history or interstitial lung disease.
  • Known connective tissue disease.
  • History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
  • Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
  • Final eligibility will be determined by the health professionals conducting the trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Erlotinib & Celecoxib
Geneesmiddel: Erlotinib & Celecoxib

Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.

Celecoxib given 400 mg orally BID continuously for 6 months.

Andere namen:
  • OSI-774, Tarceva

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4
Tijdsspanne: 12 months from time of enrollment
Participants received a fixed dose of celecoxib 400 mg orally BID continuously for 6 months. Erlotinib was dose escalated at 3 dose levels of 50, 75, and 100 mg orally every day for 6 months. Dose escalation followed a standard 3+3 escalation design.
12 months from time of enrollment
Clinical Outcome: Documented Progression
Tijdsspanne: 12 months from time of enrollment
Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
12 months from time of enrollment
Clinical Outcome: Progression to a Higher-grade Dysplasia or Carcinoma
Tijdsspanne: Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.
Response evaluation was based on pathologic examination of the degree of dysplasia observed and recorded by an expert head and neck pathologist. Pathologic complete response was defined as complete disappearance of dysplasia from the epithelium. Pathologic partial response was defined as improvement of dysplasia by at least one degree (i.e., severe dysplasia becomes moderate dysplasia). Pathologic minor response or stable disease was defined as minor focal improvement without change of degree of dysplasia (i.e., focal improvement from moderate to mild dysplasia with still moderate dysplasia overall) or no pathologic changes after treatment. Pathologic progressive disease was defined as worsening by at least one degree of dysplasia (i.e., mild to moderate dysplasia) or development of invasive cancer on or following treatment.
Up to 55 months from initiation of therapy. Median duration of follow-up was 36 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Emory University

Medewerkers

National Institutes of Health (NIH)

Onderzoekers

  • Hoofdonderzoeker: Dong Shin, MD, Emory University Winship Cancer Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2006

Primaire voltooiing (Werkelijk)

1 november 2012

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

11 april 2006

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2006

Eerst geplaatst (Schatting)

13 april 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

24 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

21 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00024922

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