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Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With Chemotherapy

5. marts 2012 opdateret af: UNC Lineberger Comprehensive Cancer Center

A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.

Studieoversigt

Status

Trukket tilbage

Betingelser

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.

Secondary

  • To estimate the progression-free survival of patients treated with this regimen.
  • To estimate the overall survival of patients treated with this regimen.
  • To estimate the toxicity of this regimen in these patients.
  • To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)
  • To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.

OUTLINE: This is a multicenter study.

Patients receive carboplatin IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and cetuximab IV over 1-2 hours on days 1, 8 and 15. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity. Treatment modifications may apply according to response.

Tumor tissue and blood samples are collected for further analysis.

After completion of study therapy, patients are followed periodically.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

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 or cytologically confirmed non-small cell lung cancer

    • Chemotherapy-naive
    • Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy
    • Stage IV disease
  • Must have pathology block or unstained slides from initial or subsequent diagnosis

    • Diagnosis made via a core biopsy (not a fine-needle aspirate) required
  • Measurable disease as defined by RECIST guidelines

    • For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field
  • Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician
  • No IgE cetuximab antibody

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Creatinine < 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis)
  • Bilirubin ≤ 1.5 times ULN
  • Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0
  • No prior severe allergic reaction to any of the following:

    • Carboplatin
    • Taxane therapy
    • Monoclonal antibody
    • Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil)
  • No active or uncontrolled infection
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Myocardial infarction within the past 6 months
    • Uncontrolled congestive heart failure
    • Cardiomyopathy with decreased ejection fraction
  • No underlying interstitial lung disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 1 week since prior and no concurrent therapeutic radiotherapy

    • Palliative radiotherapy for painful bone lesions allowed
  • At least 6 months since prior adjuvant chemotherapy
  • No investigational agent(s) within the past 30 days
  • Not requiring concurrent treatment with any of the following:

    • Ketoconazole
    • Itraconazole
    • Ritonavir
    • Amprenavir
    • Indinavir
    • Nelfinavir
    • Delavirdine
    • Voriconazole
  • No other concurrent chemotherapy or cetuximab

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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone
Tidsramme: 42 days
Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.
42 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: 2 years
Radigoraphic response of measurable disease will be assessed using RECIST critera
2 years
Overall survival
Tidsramme: 4 years
Radigoraphic response of measurable disease will be assessed using RECIST criteria
4 years
Number of subjects experiencing adverse events
Tidsramme: 1 year
Adverse events will be assessed (graded) using CTCAE criteria
1 year

Samarbejdspartnere og efterforskere

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

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 2009

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. november 2009

Datoer for studieregistrering

Først indsendt

17. oktober 2009

Først indsendt, der opfyldte QC-kriterier

17. oktober 2009

Først opslået (Skøn)

20. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2012

Sidst verificeret

1. marts 2012

Mere information

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

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