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Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00513877
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : December 31, 2014
Information provided by (Responsible Party):
Cancer Trials Ireland

Brief Summary:

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 or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: bortezomib Procedure: quality-of-life assessment Phase 2

Detailed Description:



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


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
Study Start Date : May 2006
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Bortezomib 1.6mg/m2 Drug: bortezomib
Procedure: quality-of-life assessment

Primary Outcome Measures :
  1. Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria [ Time Frame: 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.

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: 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. ]
  2. Overall survival [ Time Frame: 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. ]
  3. Safety [ Time Frame: 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. ]
  4. Quality of life [ Time Frame: Week 1, Week 10 and end of treatment ]
    Quality of life will be assessed using the Lung Cancer Symptom Score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00513877

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Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Cork University Hospital
Cork, Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24
St. Vincent's University Hospital
Dublin, Ireland, 4
Mater Misericordiae University Hospital
Dublin, Ireland, 7
St. James's Hospital
Dublin, Ireland, 8
Beaumont Hospital
Dublin, Ireland, 9
Galway University Hospital
Galway, Ireland
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 BE
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT9 7BL
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Cancer Trials Ireland
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Principal Investigator: Dean A. Fennell, MD, PhD Centre for Cancer Research and Cell Biology at Queen's University Belfast
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cancer Trials Ireland Identifier: NCT00513877    
Other Study ID Numbers: 05-10 ICORG
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: January 2013
Keywords provided by Cancer Trials Ireland:
recurrent malignant mesothelioma
stage IA malignant mesothelioma
stage IB malignant mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma
stage IV malignant mesothelioma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents