Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159484
Status:
UNKNOWN
Last Update Posted:
2017-06-27
First Post:
2005-09-08
Brief Title:
Phase III Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase III Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer CEPO906AUS10
Status:
UNKNOWN
Status Verified Date:
2017-06
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:
This study is for people with advanced colorectal cancer This study uses the drugs Celebrex and EPO906 EPO906 is an experimental drug that has not been approved by the FDA EPO906 is a drug that has been shown in the laboratory to cause cancer cells to die and prevents them from growing and reproducing Celebrex is a drug that is approved by the FDA for the treatment of arthritis and prevention of colon polyps Colon polyps are small growths in the colon If not surgically removed some colon polyps can become cancerous Some studies have shown that Celebrex may reduce the side effects of chemotherapy Other studies have shown that it may increase the effectiveness of some chemotherapy Celebrex is not approved by the FDA for reducing the side effects of chemotherapy or improving the effectiveness of chemotherapy The combination of EPO906 and Celebrex in this study is experimental
The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906
The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex The dose of Celebrex will remain the same for the whole study Higher doses of EPO906 will be given to each group of patients The increase of EPO906 will stop once more than one patient has serious side effects The highest dose of EPO906 that can be given with Celebrex without serious side effects will be called the pilot dose
The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs Another purpose of this study is to see how the body processes the EPO906 and Celebrex This study will also look at the side effects of these drugs In this study we will measure how long subjects live how often tumors shrink after receiving the study drugs and how long it takes for tumors to increase in size after receiving the study drugs This study will also measure the levels of genes which are the cells blueprint in participants tumors Several genes can affect how peoples bodies react to the cancer drugs Genes will also be measured in participants blood We want to see if these predict response to the study drugs
The main goal of this study is to see if adding the drug Celebrex to the drug EPO906 will decrease the amount of diarrhea seen in patients that receive EPO906
The goal of the first phase of this study is to find the highest dose of EPO906 that can be given safely with Celebrex The dose of Celebrex will remain the same for the whole study Higher doses of EPO906 will be given to each group of patients The increase of EPO906 will stop once more than one patient has serious side effects The highest dose of EPO906 that can be given with Celebrex without serious side effects will be called the pilot dose
The goal of the second phase of this study is to find out how tumors respond to these doses of the drugs Another purpose of this study is to see how the body processes the EPO906 and Celebrex This study will also look at the side effects of these drugs In this study we will measure how long subjects live how often tumors shrink after receiving the study drugs and how long it takes for tumors to increase in size after receiving the study drugs This study will also measure the levels of genes which are the cells blueprint in participants tumors Several genes can affect how peoples bodies react to the cancer drugs Genes will also be measured in participants blood We want to see if these predict response to the study drugs
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?:
None