Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

21 oktober 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

17

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University Winship Cancer Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Erlotinib & Celecoxib
Läkemedel: 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.

Andra namn:
  • OSI-774, Tarceva

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dose Escalation and Toxicity: Toxicities Including Grades 1 to 4
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Emory University

Samarbetspartners

National Institutes of Health (NIH)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2006

Primärt slutförande (Faktisk)

1 november 2012

Avslutad studie (Faktisk)

1 november 2012

Studieregistreringsdatum

Först inskickad

11 april 2006

Först inskickad som uppfyllde QC-kriterierna

11 april 2006

Första postat (Uppskatta)

13 april 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 oktober 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 oktober 2014

Senast verifierad

1 oktober 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00024922

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera