Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040391
Status:
TERMINATED
Last Update Posted:
2016-12-01
First Post:
2002-06-26
Brief Title:
A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan5FULeucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
Sponsor:
Celgene Corporation
Organization:
Celgene Corporation
Study Overview
Official Title:
A Phase II Randomized Open-label Controlled Dose-elevation Multicenter Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan5FULeucovorin Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan also known as CPT-11 Camptosar 5-fluorouracil also known as 5-FU and leucovorin also known as LV This is known as the triple therapy One of the major side effects of CPT-115-FULV chemotherapy treatment is diarrhea The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors
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