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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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

Conditions

Malignant Mesothelioma

Interventions

bortezomib

quality-of-life assessment

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.