Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
NCT ID: NCT00513877
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of bortezomib and how well it works in treating patients with malignant pleural mesothelioma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bortezomib 1.6mg/m2
bortezomib
quality-of-life assessment
Interventions
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bortezomib
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
PATIENT CHARACTERISTICS:
* 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
18 Years
ALL
No
Sponsors
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Cancer Trials Ireland
NETWORK
Responsible Party
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Principal Investigators
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Dean A. Fennell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Locations
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Universitair Ziekenhuis Gent
Ghent, , Belgium
Cork University Hospital
Cork, , Ireland
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
St. James's Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
Galway University Hospital
Galway, , Ireland
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Saint Bartholomew's Hospital
London, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Walter RFH, Sydow SR, Berg E, Kollmeier J, Christoph DC, Christoph S, Eberhardt WEE, Mairinger T, Wohlschlaeger J, Schmid KW, Mairinger FD. Bortezomib sensitivity is tissue dependent and high expression of the 20S proteasome precludes good response in malignant pleural mesothelioma. Cancer Manag Res. 2019 Sep 24;11:8711-8720. doi: 10.2147/CMAR.S194337. eCollection 2019.
Other Identifiers
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ICORG-05-10
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-004420-39
Identifier Type: -
Identifier Source: secondary_id
EU-20748
Identifier Type: -
Identifier Source: secondary_id
05-10 ICORG
Identifier Type: -
Identifier Source: org_study_id