Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252564
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2005-11-09
Brief Title:
Cetuximab Bevacizumab 5FULeucovorin vs Oxaliplatin Bevacizumab 5FULeucovorin in Metastatic Colorectal Cancer
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
Randomized PhIII Trial of Cetuximab Bevacizumab Biweekly Infusional 5FULeucovorin FOLF-CB vs Oxaliplatin Bevacizumab Biweekly Infusional 5FULeucovorin Bev-FOLFOX in First Line Treatment of Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2018-09
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:
The purpose of this study is to compare the rates of Progression-Free Survival PFS at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer
Detailed Description:
This is a Phase III open label nonblinded study A total of 240 eligible patients will be randomized on a 11 basis to either treatment Arm
In this trial we will compare the efficacy safety and tolerability of this novel combination of biweekly infusional 5-FUleucovorin plus cetuximab and bevacizumab FOLF-CB to the current standard of care biweekly infusional 5-FUleucovorin plus oxaliplatin and bevacizumab Bev-FOLFOX For practical purposes this study will be a head to head comparison of oxaliplatin versus cetuximab since the other components of both regimens will be the same
In this trial we will compare the efficacy safety and tolerability of this novel combination of biweekly infusional 5-FUleucovorin plus cetuximab and bevacizumab FOLF-CB to the current standard of care biweekly infusional 5-FUleucovorin plus oxaliplatin and bevacizumab Bev-FOLFOX For practical purposes this study will be a head to head comparison of oxaliplatin versus cetuximab since the other components of both regimens will be the same
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