Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513877
Status:
COMPLETED
Last Update Posted:
2014-12-31
First Post:
2007-08-08
Brief Title:
Bortezomib in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
Cancer Trials Ireland
Organization:
Cancer Trials Ireland
Study Overview
Official Title:
An Open Label Phase II Multicentre Clinical Trial of Single Agent Bortezomib in Patients With Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICORG-05-10 | None | None | None |
| EUDRACT-2005-004420-39 | None | None | None |
| EU-20748 | None | None | None |