Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215722
Status:
UNKNOWN
Last Update Posted:
2007-04-06
First Post:
2005-09-20
Brief Title:
XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Grupo de Investigacao do Cancro Digestivo
Organization:
Grupo de Investigacao do Cancro Digestivo
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 first phase II trial with cetuximab and FOLFOX as 1st line therapy for MCRC presented at ASCO 2004 showed a 81 response rate with no unexpected toxicities for the combination
This study is aimed at establishing the efficacy and safety of the combination cetuximabXELOX as first line therapy in patients with MCRC
This study is aimed at establishing the efficacy and safety of the combination cetuximabXELOX as first line therapy in patients with MCRC
Detailed Description:
The phase II trials with XELOX demonstrated that is a highly effective first-line treatment for metastatic colorectal cancer with response rates similar to the regimens with oxaliplatin and infusional 5-FULV FOLFOX but more convenient and likely to be preferred by both patients and health care providers
Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease which suggests that a much greater degree of benefit may ensue when it is used at an earlier stage of the disease course
The first phase II trial with cetuximab and FOLFOX as 1st line therapy for MCRC presented at ASCO 2004 showed a 81 response rate with no unexpected toxicities for the combination
This study is aimed at establishing the efficacy and safety of the combination cetuximabXELOX as first line therapy in patients with MCRC
Cetuximab has a significant anti-cancer activity in the setting of chemo-resistant disease which suggests that a much greater degree of benefit may ensue when it is used at an earlier stage of the disease course
The first phase II trial with cetuximab and FOLFOX as 1st line therapy for MCRC presented at ASCO 2004 showed a 81 response rate with no unexpected toxicities for the combination
This study is aimed at establishing the efficacy and safety of the combination cetuximabXELOX as first line therapy in patients with MCRC
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