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| Sponsor: | All Ireland Cooperative 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: | Allocation: Non-Randomized Masking: 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 |
| Estimated Enrollment: | 111 |
| Study Start Date: | May 2006 |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Meets 1 of the following criteria for first-line or second-line 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
Pleural effusions should be drained before treatment whenever possible
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled or severe cardiovascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since enrollment in another therapeutic clinical trial (i.e., received an experimental drug or used an experimental medical device)
No concurrent experimental or antineoplastic agent other than bortezomib
Contacts and 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 | |
| Cork University Hospital | Recruiting |
| Cork, Ireland | |
| Contact: Branislav Bystricky 353-21-492-0052 branislav.bystricky@mailp.hse.ie | |
| 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 | |
| Mater Misericordiae University Hospital | Recruiting |
| Dublin, Ireland, 7 | |
| Contact: Desmond N. Carney, MD 353-1-838-4444 | |
| St. James's Hospital | Recruiting |
| Dublin, Ireland, 8 | |
| Contact: Kenneth O'Byrne, MD 353-1-410-3752 | |
| Beaumont Hospital | Recruiting |
| Dublin, Ireland, 9 | |
| Contact: Oscar Breathnach, MD 353-1-809-2373 | |
| St. Vincent's University Hospital | Recruiting |
| Dublin, Ireland, 4 | |
| Contact: John Crown, MD 011-353-1-269-5033 | |
| Galway University Hospital | Recruiting |
| Galway, Ireland | |
| Contact: Maccon M. Keane, MD 353-91-524-222 maccon.keane@mailn.hse.ie | |
| 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 | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Jeremy Steele, MD 44-207-601-7577 | |
| 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 | |
| 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 | |
| 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 | |
| Principal Investigator: | Dean A. Fennell, MD, PhD | Centre for Cancer Research and Cell Biology at Queen's University Belfast |
More Information
| ClinicalTrials.gov Identifier: | NCT00513877 History of Changes |
| Other Study ID Numbers: | CDR0000560151, ICORG-05-10, EUDRACT-2005-004420-39, EU-20748 |
| Study First Received: | August 8, 2007 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Unspecified |
|
recurrent malignant mesothelioma stage IA malignant mesothelioma stage IB malignant mesothelioma |
stage II malignant mesothelioma stage III malignant mesothelioma stage IV malignant mesothelioma |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Bortezomib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |