Ignite Creation Date:
2025-12-18 @ 8:39 AM
Ignite Modification Date:
2025-12-18 @ 8:39 AM
Study NCT ID:
NCT00251485
Status:
None
Last Update Posted:
2008-08-21 00:00:00
First Post:
2005-11-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer
Status:
None
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:
The current treatment options for metastatic colon cancer are in need of further improvement. The three-drug combination of oxaliplatin with 5-FU/LV 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 alone.30,31 Cetuximab has also been shown to be safe and effective when administered with infusional 5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to a 5-FU/LV/oxaliplatin-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 IIIB/IV, 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 IIIB/IV, 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.
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?: