Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321100
Status:
TERMINATED
Last Update Posted:
2022-01-12
First Post:
2006-05-01
Brief Title:
Combination of Cetuximab Capecitabine and Oxaliplatin With or Without Bevacizumab
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study of the Combination of Cetuximab Capecitabine and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment closed 10152008 based on data about KRAS
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab capecitabine and oxaliplatin with out without bevacizumab
Detailed Description:
Research has shown that the more drug treatments patients with cancer of the colon or rectum receive the longer they live One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live However it can increase the risk of stroke and heart attack Bevacizumab is currently a standard part of treatment for colorectal cancer Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer It may be helpful with initial chemotherapy and with bevacizumab One goal of this study is to find out the response rate chance of tumor shrinking with two treatments for colorectal cancer All patients will get capecitabine oxaliplatin and cetuximab Half will receive bevacizumab All drugs in this study are approved to treat colorectal cancer This research study is being done to find the best safest way to combine these therapies
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