Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346645
Status:
TERMINATED
Last Update Posted:
2013-02-06
First Post:
2006-06-29
Brief Title:
A Phase II Study of Velcade in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
A Phase II Study of Velcade Bortezomib in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer NSCLC Who Have Not Received Prior Chemotherapy
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
stopped after planned interim analysis for lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease
Detailed Description:
Chemotherapy for non-small-cell lung cancer NSCLC mainly Cisplatin-based combinations provides a measurable but modest survival benefit for selected patients with advanced disease Advanced NSCLC remains largely fatal with the positive impact of chemotherapy limited by intrinsic and acquired resistance manifested clinically by early progression and transient responses Current chemotherapy regimens have limited efficacy with a magnitude of survival benefit that is still modest and lead to significant toxicity with many patients unable to receive this kind of treatment even in first line setting There is therefore a great need to provide patients with less toxic agents such as the novel targeted therapies with the potential to improve the efficacy and maintain a good quality of life Bortezomib a proteasome inhibitor has shown benefit as single agent in pretreated patients with similar or lesser toxicity compared to chemotherapy The current project is a phase II trial that will include 46 patients with advanced NSCLC and without prior chemotherapy An early tumor assessment after 6 weeks of therapy will be performed combined with regular clinical and symptom assessment to allow for rapid and appropriate management of non-responding patients with cross over to another therapy as per the investigator and patient choice The primary objective is efficacy of bortezomib as determined by the rate of no progression at 6 weeks Secondary objectives are efficacy of bortezomib as determined by objective response rate incidence of CR and PR disease control rate CR PR and stabilization duration of disease control duration of objective response progression-free survivaloverall survival safety of bortezomib rate of doublet therapy in second line
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 |
|---|---|---|---|
| CSET 1192 | None | None | None |