Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
- Conditions
- Malignant Mesothelioma
- Interventions
- Procedure: quality-of-life assessment
- Registration Number
- NCT00513877
- Lead Sponsor
- Cancer Trials Ireland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib 1.6mg/m2 quality-of-life assessment - Bortezomib 1.6mg/m2 bortezomib -
- Primary Outcome Measures
Name Time Method Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria 28 days prior to baseline, at 10 weeks and at end of treatment 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.
- Secondary Outcome Measures
Name Time Method Safety The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of the pre-determined normal ranges. Overall survival Overall Survival is measured from the date of first treatment to the date of the subject's death. If the subject is alive or the vital status is unknown, the date of death will be censored at the date that the subject is last known to be alive. Quality of life Week 1, Week 10 and end of treatment Quality of life will be assessed using the Lung Cancer Symptom Score
Time to disease progression Time to disease progression is measured from first treatment until the date of PD or death whichever is first reported. Subjects who did not progress or die will be censored at the day of their last tumour assessment.
Trial Locations
- Locations (13)
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Ireland
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Cork University Hospital
🇮🇪Cork, Ireland
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Galway University Hospital
🇮🇪Galway, Ireland
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
St. James's Hospital
🇮🇪Dublin, Ireland
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom