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Spots Global Cancer Trial Database for Bortezomib in Treating Patients With Malignant Pleural Mesothelioma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Dean A. Fennell, MD, PhD

Affiliation: Centre for Cancer Research and Cell Biology at Queen's University Belfast

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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