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Brief Title: Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
Official Title: An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
Study ID: NCT00513877
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.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Dean A. Fennell, MD, PhD
Affiliation: Centre for Cancer Research and Cell Biology at Queen's University Belfast
Role: PRINCIPAL_INVESTIGATOR