Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444678
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2007-03-07
Brief Title:
Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin C-CO2 in the Treatment of Patients With KRAS Wild Type Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum who have not received prior chemotherapy for metastatic disease
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 fluorouracilleucovorin in the second-line treatment of metastatic colorectal cancer have shown a significant increase in response rate compared to 5-FULV alone Oxaliplatin has recently been FDA-approved for this indication and is now a standard first-line agent in combination with a fluoropyrimidine Cetuximab a chimeric monoclonal antibody against the growth factor receptor has shown activity with and without irinotecan in subjects with colorectal cancer refractory to irinotecan alone 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 fluoropyrimidineoxaliplatin-based regimen in the 1st line setting should be explored The use of the oral fluoropyrimidine capecitabine to replace infusional 5FU has been widely used for improved convenience and possible safety We have chosen a modified biweekly CapeOx capecitabine plus oxaliplatin regimen due to its improved tolerance and response rate with a fixed dose of capecitabine given its widespread practice and ease of use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA225056 | OTHER | Bristol-Myers Squibb | None |