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Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

2. april 2013 opdateret af: William Pao, MD, Vanderbilt-Ingram Cancer Center

Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.

RATIONALE: Erlotinib may stop the growth of tumor cells 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 advanced non-small cell lung cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

  • Assess the quality of life of patients treated with this regimen.
  • Determine the duration of response and time to disease progression in patients treated with this regimen.
  • Determine the median survival of patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital
    • New York
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)

    • Stage IIIB (malignant pleural or pericardial effusion) disease
    • Stage IV disease
    • Recurrent and/or medically inoperable disease
  • Measurable or evaluable indicator lesions
  • No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
  • Life expectancy ≥ 8 weeks
  • WBC ≥ 3,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.0 mg/dL
  • AST ≤ 2 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

  • No significant medical history or unstable medical condition, including any of the following:

    • Unstable systemic disease
    • Congestive heart failure
    • Recent myocardial infarction
    • Unstable angina
    • Active infection
    • Uncontrolled hypertension
  • No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
  • At least 3 weeks since prior chemotherapy
  • No more than 1 prior chemotherapy regimen for NSCLC
  • No prior systemic cytotoxic chemotherapy for other malignant diseases
  • No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib)
  • No concurrent radiotherapy or chemotherapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Therapeutic Intervention
Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
Medicin: erlotinib hydrochloride
All patients will receive 150 mg orally daily
Andre navne:
  • Tarceva, OSI-774

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major objective response rate (complete response and partial response)
Tidsramme: At 4 weeks and then every 8 weeks
Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions
At 4 weeks and then every 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Worst grade toxicity
Tidsramme: weekly for 4 weeks, then every 8 weeks to discontinuation of drug
Number of patients with worst-grade toxicity at each of five grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death) following NCI Common Toxicity Criteria, v. 2. Drug is discontinued for disease progression, unacceptable toxicity, patient undergoes radiation or other chemotherapy, or withdraws from study
weekly for 4 weeks, then every 8 weeks to discontinuation of drug
Quality of life as measured by the Lung Cancer Symptom Scale for patients
Tidsramme: baseline, every week for 5 weeks, and then every 4 weeks
The Lung Cancer Symptom Scale for patients is a nine-item scale with 0 = lowest rating (least) to 100 = highest rating (worst) for the measurement of symptom burden for loss of appetite, fatigue, cough, dyspnea, hemoptysis, activity, quality of life, lung cancer symptoms, and pain.
baseline, every week for 5 weeks, and then every 4 weeks
Survival
Tidsramme: from study entry to date of death or last date known alive
Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.
from study entry to date of death or last date known alive

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt-Ingram Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: William Pao, MD, Vanderbilt-Ingram Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2002

Primær færdiggørelse (Faktiske)

1. oktober 2007

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

27. december 2006

Først indsendt, der opfyldte QC-kriterier

27. december 2006

Først opslået (Skøn)

28. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VCC THO 0214
  • P30CA068485 (U.S. NIH-bevilling/kontrakt)
  • P50CA090949 (U.S. NIH-bevilling/kontrakt)
  • VU-VCC-THO-0214
  • VU-VCC-IRB-02-0168
  • GENENTECH-VU-VCC-THO-0214

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med erlotinib hydrochloride

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner