Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227019
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2005-09-08
Brief Title:
Phase 2 Trial of Bevacizumab in Combination With Pemetrexed
Sponsor:
Heather Wakelee
Organization:
Stanford University
Study Overview
Official Title:
Phase II Trial of Bevacizumab in Combination With Pemetrexed as Second Line Therapy in Patients With Stable Brain Metastases From Non-small Cell Lung Cancer NSCLC Excluding Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer NSCLC patients with stable brain metastases as second-line chemotherapy while evaluating progression-free survival PFS and overall survival OS
Detailed Description:
Brain metastases are a common complication of advanced non-small-cell lung cancer NSCLC both at initial presentation and at the time of disease progression Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier However as survival has improved some trials have included such patients often finding similar benefit to patients with metastatic disease elsewhere
Bevacizumab is a recombinant humanized monoclonal antibody against vascular endothelial growth factor has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC This drug is normally used as a first line chemotherapy Pemetrexed is a multi-targeted anti-folate agentwhich is approved for use in first-line with platinum maintenance and second-line treatment of advanced nonsquamous NSCLC Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases
Bevacizumab is a recombinant humanized monoclonal antibody against vascular endothelial growth factor has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC This drug is normally used as a first line chemotherapy Pemetrexed is a multi-targeted anti-folate agentwhich is approved for use in first-line with platinum maintenance and second-line treatment of advanced nonsquamous NSCLC Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases
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 |
|---|---|---|---|
| LUN0014 | OTHER | OnCore | None |
| 95913 | OTHER | None | None |