Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251524
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-11-08
Brief Title:
A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC
Status:
COMPLETED
Status Verified Date:
2012-05
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 is a Phase II open-label non-randomized study in patients with advanced non-squamous NSCLC
Each cycle will be 21 days Patients will be evaluated every 2 cycles 6 weeks for response using RECIST criteria Those patients achieving stable disease or better will continue therapy Those patients experiencing progressive disease will be taken off study
Patients will receive 6 cycles of Eloxatin Alimta and Bevacizumab After the 6 cycles patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity
Note Once patient has completed the 6 cycles of Eloxatin Alimta and Bevacizumab and is receiving single-agent Bevacizumab assessment of response will be performed every 3 cycles every 9 weeks using RECIST criteria
Each cycle will be 21 days Patients will be evaluated every 2 cycles 6 weeks for response using RECIST criteria Those patients achieving stable disease or better will continue therapy Those patients experiencing progressive disease will be taken off study
Patients will receive 6 cycles of Eloxatin Alimta and Bevacizumab After the 6 cycles patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity
Note Once patient has completed the 6 cycles of Eloxatin Alimta and Bevacizumab and is receiving single-agent Bevacizumab assessment of response will be performed every 3 cycles every 9 weeks using RECIST criteria
Detailed Description:
None
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