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Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

30 december 2014 uppdaterad av: Cancer Trials Ireland

An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

Primary

  • Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.

Secondary

  • Assess additional clinical efficacy of bortezomib based on the evaluation of time to early disease progression and median overall 2-year survival rate.
  • Assess safety and toxicity in these patients.
  • Assess quality of life using the Lung Cancer Symptom Score.

OUTLINE: This is a multicenter study. Patients are stratified according to current treatment (first-line vs second-line)

Patients receive bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients exhibiting objective response or stable disease by week 20, may continue treatment at the discretion of the investigator until evidence of disease progression.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed for up to 2 years.

PROJECTED ACCRUAL: 57 first-line setting and 54 second-line setting patients will be accrued for this study.

Studietyp

Interventionell

Inskrivning (Faktisk)

33

Fas

  • Fas 2

Kontakter och platser

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

Studieorter

  • Belgien
      • Ghent, Belgien, B-9000
        • Universitair Ziekenhuis Gent
  • Irland
      • Cork, Irland
        • Cork University Hospital
      • Dublin, Irland, 9
        • Beaumont Hospital
      • Dublin, Irland, 7
        • Mater Misericordiae University Hospital
      • Dublin, Irland, 4
        • St. Vincent'S University Hospital
      • Dublin, Irland, 24
        • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
      • Dublin, Irland, 8
        • St. James's Hospital
      • Galway, Irland
        • Galway University Hospital
  • Nederländerna
      • Amsterdam, Nederländerna, 1066 BE
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Storbritannien
    • England
      • London, England, Storbritannien, EC1A 7BE
        • Saint Bartholomew's Hospital
      • Sutton, England, Storbritannien, SM2 5PT
        • Royal Marsden - Surrey
    • Northern Ireland
      • Belfast, Northern Ireland, Storbritannien, BT9 7BL
        • Centre for Cancer Research and Cell Biology at Queen's University Belfast
    • Scotland
      • Glasgow, Scotland, Storbritannien, G11 6NT
        • Beatson West of Scotland Cancer Centre

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically confirmed malignant pleural mesothelioma

  • Meets 1 of the following criteria for first-line or second-line chemotherapy:

    • Patients in the first-line setting must be unsuitable for, cannot access locally, or refuse combination chemotherapy

    • Patients in the second-line setting must be unsuitable for, cannot access locally, or refuse cytotoxic chemotherapy after failure of a first-line regimen

      • Second-line patients may not have received more than 1 prior line of antineoplastic treatment for this cancer

  • Pleural effusions should be drained before treatment whenever possible

    • Talc or tetracycline pleurodesis may be used per standard practice for uncontrollable pleural effusions (recurrent despite regular drainage)

Exclusion criteria:

  • Symptomatic or known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Hemoglobin ≥ 10 g/dL
  • Neutrophil count ≥ 1,500 mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine clearance ≥ 30 mL/min
  • AST and ALT < 3 times upper limit of normal
  • Fertile patients must use effective contraception during study therapy

Exclusion criteria:

  • Pregnant or breastfeeding
  • History of prior malignant tumor within the past 3 years except for nonmelanoma skin tumor or carcinoma in situ of the cervix
  • Patients suitably fit to receive a platinum doublet based chemotherapy (first-line only)

  • Uncontrolled or severe cardiovascular disease including any of the following:

    • Myocardial infarction within the past 6 months
    • New York Heart Association class III or IV heart failure
    • Uncontrolled angina
    • Clinically significant pericardial disease
    • Cardiac amyloidosis
  • Neuropathy ≥ grade 2 OR grade 1 with pain
  • Serious medical (e.g., uncontrolled diabetes, hepatic disease, or infection) or psychiatric illness that would interfere with study participation
  • Patients with known HIV or hepatitis B or C infection

PRIOR CONCURRENT THERAPY:

  • No prior bortezomib
  • No prior extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrollment
  • No preplanned surgery or procedures that would interfere with the study

  • More than 4 weeks since enrollment in another therapeutic clinical trial (i.e., received an experimental drug or used an experimental medical device)

    • Concurrent participation in non-treatment studies is allowed provided they do not interfere with participation in this study

  • No concurrent experimental or antineoplastic agent other than bortezomib

    • Medications that may have antineoplastic activity, but are taken for other reasons than specific antineoplastic effect (e.g., megestrol [Megace®], cyclo-oxygenase-2 [COX-2] inhibitors, or bisphosphonates) are allowed

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Bortezomib 1.6mg/m2
Procedur: livskvalitetsbedömning
Läkemedel: bortezomib

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
Tidsram: 28 days prior to baseline, at 10 weeks and at end of treatment
The objective tumour response rate is a primary endpoint of the study. This will be a proportion of evaluable subjects who achieve a confirmed CR or PR per modified RECIST guidelines within four cycles (20 weeks) of treatment.
28 days prior to baseline, at 10 weeks and at end of treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to disease progression
Tidsram: Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
Overall survival
Tidsram: Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive.
Safety
Tidsram: The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.
The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges.
Quality of life
Tidsram: Week 1, Week 10 and end of treatment
Quality of life will be assessed using the Lung Cancer Symptom Score
Week 1, Week 10 and end of treatment

Samarbetspartners och utredare

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

Sponsor

Cancer Trials Ireland

Utredare

  • Huvudutredare: Dean A. Fennell, MD, PhD, Centre for Cancer Research and Cell Biology at Queen's University Belfast

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 maj 2006

Primärt slutförande (Faktisk)

1 december 2009

Studieregistreringsdatum

Först inskickad

8 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

8 augusti 2007

Första postat (Uppskatta)

9 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

31 december 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 december 2014

Senast verifierad

1 januari 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 05-10 ICORG
  • ICORG-05-10
  • EUDRACT-2005-004420-39
  • EU-20748

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