Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
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ClinicalTrials.gov Identifier: NCT00513877 |
Recruitment Status
:
Completed
First Posted
: August 9, 2007
Last Update Posted
: December 31, 2014
|
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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 |
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.
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 |

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00513877
Belgium | |
Universitair Ziekenhuis Gent | |
Ghent, Belgium, B-9000 | |
Ireland | |
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 | |
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 |
Principal Investigator: | Dean A. Fennell, MD, PhD | Centre for Cancer Research and Cell Biology at Queen's University Belfast |
Responsible Party: | Cancer Trials Ireland |
ClinicalTrials.gov Identifier: | NCT00513877 History of Changes |
Other Study ID Numbers: |
05-10 ICORG ICORG-05-10 EUDRACT-2005-004420-39 EU-20748 |
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:
Mesothelioma Lung Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Bortezomib Antineoplastic Agents |