Full Text View
Tabular View
No Study Results Posted
Related Studies
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2007
First Received: August 8, 2007   Last Updated: February 6, 2009   History of Changes
Sponsor: Irish Clinical Oncology Research Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513877
  Purpose

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.


Condition Intervention Phase
Malignant Mesothelioma
Drug: bortezomib
Procedure: quality-of-life assessment
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: May 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513877

Locations
Belgium
Universitair Ziekenhuis Gent Recruiting
Ghent, Belgium, B-9000
Contact: Jan P. Van Meerbeeck, MD, PhD     32-9-332-2611     jan.vanmeerbeeck@ugent.be    
Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital Recruiting
Dublin, Ireland, 24
Contact: Ray McDermott, MD     353-1-414-2012     ray.mcdermott@amnch.ie    
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Oscar Breathnach, MD     353-1-809-2373        
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland, 7
Contact: Desmond N. Carney, MD     353-1-838-4444        
Galway University Hospital Recruiting
Galway, Ireland
Contact: Maccon M. Keane, MD     353-91-524-222     maccon.keane@mailn.hse.ie    
Cork University Hospital Recruiting
Cork, Ireland
Contact: Branislav Bystricky     353-21-492-0052     branislav.bystricky@mailp.hse.ie    
St. James's Hospital Recruiting
Dublin, Ireland, 8
Contact: Kenneth O'Byrne, MD     353-1-410-3545        
St. Vincent's University Hospital Recruiting
Dublin, Ireland, 4
Contact: John Crown, MD     011-353-1-269-5033        
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands, 1066 BE
Contact: Paul Baas, MD, PhD     020-512-2958     p.baas@nki.nl    
United Kingdom, England
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Mary O'Brien, MD     44-20-8661-3276     mary.o'brien@rmh.nhs.uk    
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Jeremy Steele, MD     44-207-601-7577        
United Kingdom, Northern Ireland
Centre for Cancer Research and Cell Biology at Queen's University Belfast Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 7BL
Contact: Dean A. Fennell, MD, PhD     44-28-9097-2960     d.fennell@qub.ac.uk    
United Kingdom, Scotland
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: David J. Dunlop, MD     44-141-211-2837     dunlopdj@excute.com    
Sponsors and Collaborators
Irish Clinical Oncology Research Group
Investigators
Principal Investigator: Dean A. Fennell, MD, PhD Centre for Cancer Research and Cell Biology at Queen's University Belfast
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000560151, ICORG-05-10, EUDRACT-2005-004420-39, EU-20748
Study First Received: August 8, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00513877     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
localized malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Neoplasms
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009