Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
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.
Procedure: quality-of-life assessment
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma|
- Objective tumor response rate (complete response or partial response) as assessed by modified RECIST criteria [ Time Frame: 28 days prior to baseline, at 10 weeks and at end of treatment ] [ Designated as safety issue: No ]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.
- Time to disease progression [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Week 1, Week 10 and end of treatment ] [ Designated as safety issue: No ]Quality of life will be assessed using the Lung Cancer Symptom Score
|Study Start Date:||May 2006|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Bortezomib 1.6mg/m2||Drug: bortezomib Procedure: quality-of-life assessment|
- Assess the clinical efficacy of bortezomib based on the evaluation of objective tumor response rate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513877
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Cork University Hospital|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|St. James's Hospital|
|Dublin, Ireland, 8|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|Dublin, Ireland, 9|
|Galway University Hospital|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 BE|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Centre for Cancer Research and Cell Biology at Queen's University Belfast|
|Belfast, Northern Ireland, United Kingdom, BT9 7BL|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Principal Investigator:||Dean A. Fennell, MD, PhD||Centre for Cancer Research and Cell Biology at Queen's University Belfast|