Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177307
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2005-09-12
Brief Title:
Safety and Efficacy Study Using Bevacizumab Capecitabine and Oxaliplatin for Colorectal Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Study of the A-ICOX Regimen Consisting of Bevacizumab Avastinâ Intermittent Dose Capecitabine Xelodaâ and Oxaliplatin Eloxatinâ in Patients With Untreated Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
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 study of the drug combination of Oxaliplatin Avastin and capecitabine This is an open-label study
Detailed Description:
Ongoing clinical trials are now evaluating the addition of bevacizumab to standard chemotherapeutic regimens for colorectal cancer such as FOLFOX or FOLFIRI In these studies the addition of bevacizumab has been safe and has not resulted in significantly increased toxicity Our proposed regimen has the advantage of being easily administered in the outpatient setting with potential for enhanced activity and needs to be evaluated in a clinical trial
The patterns of care for CRC have shifted IFL previously the standard of care is now proven to be an inferior regimen compared to FOLFOX4 8 The recent FDA approval in February 2004 of bevacizumab for first line therapy which states that bevacizumab is an approved agent in combination with a 5-FU regimen gives no clear guidelines as to the best regimen This is an issue that needs to be evaluated rapidly in clinical trials and it is clear that a combination of 5-FU or capecitabine with oxaliplatin and bevacizumab is one of the most active and well-tolerated regimens The optimum sequence schedule and doses needs to determined in clinical trials
The patterns of care for CRC have shifted IFL previously the standard of care is now proven to be an inferior regimen compared to FOLFOX4 8 The recent FDA approval in February 2004 of bevacizumab for first line therapy which states that bevacizumab is an approved agent in combination with a 5-FU regimen gives no clear guidelines as to the best regimen This is an issue that needs to be evaluated rapidly in clinical trials and it is clear that a combination of 5-FU or capecitabine with oxaliplatin and bevacizumab is one of the most active and well-tolerated regimens The optimum sequence schedule and doses needs to determined in clinical trials
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