Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251485
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2005-11-08
Brief Title:
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2008-08
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 histologically or pathologically confirmed diagnosis of stage IIIBIV EGFR adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease
Primary Study Endpoint
To assess the response rate progression-free survival and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer
Secondary Study Endpoints
To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 cetuximab regimen
Primary Study Endpoint
To assess the response rate progression-free survival and overall safety profile of a modified FOLFOX 6 plus cetuximab regimen in the first-line treatment of patients with metastatic colorectal cancer
Secondary Study Endpoints
To assess overall survival of patients with metastatic colorectal cancer who receive first-line therapy with a modified FOLFOX 6 cetuximab regimen
Detailed Description:
The current treatment options for metastatic colon cancer are in need of further improvement The three-drug combination of oxaliplatin with 5-FULV for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate compared to IFL irinotecan and bolus 5-FU plus leucovorin and IROX irinotecan plus oxaliplatin Cetuximab has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone3031 Cetuximab has also been shown to be safe and effective when administered with infusional 5-FUfolinic acid plus irinotecan These results suggest that the addition of cetuximab to a 5-FULVoxaliplatin-based regimen FOLFOX used in the 1st line setting may lead to the development of more treatment options for subjects with advanced colorectal cancer
This is a Phase II open label non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIBIV EGFR adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease
Patients will receive a modified FOLFOX 6 regimen 5-FU leucovorin and oxaliplatin every 2 weeks in combination with cetuximab given weekly
Patients will be evaluated for response and progression-free survival Overall survival will also be evaluated as well as the safety profile of the regimen
This is a Phase II open label non-randomized study in patients with histologically or pathologically confirmed diagnosis of stage IIIBIV EGFR adenocarcinoma of the colon or rectum who have not received prior chemotherapy for their metastatic disease
Patients will receive a modified FOLFOX 6 regimen 5-FU leucovorin and oxaliplatin every 2 weeks in combination with cetuximab given weekly
Patients will be evaluated for response and progression-free survival Overall survival will also be evaluated as well as the safety profile of the regimen
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