An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria
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.
28 days prior to baseline, at 10 weeks and at end of treatment
Dean A. Fennell, MD, PhD
Centre for Cancer Research and Cell Biology at Queen's University Belfast
Ireland: Irish Medicines Board