Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037180
Status:
TERMINATED
Last Update Posted:
2008-09-29
First Post:
2002-05-16
Brief Title:
For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Phase II Randomized Double-Blind Multicenter Trial Of Celecoxib Vs Placebo For The Prevention Of Diarrhea Associated With CPT-115fuLV Chemotherapy In Patients With Previously Untreated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2008-09
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 Diarrhea Prevention with an investigational drug trial will evaluate whether adding an investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan also known as CPT-11 Camptosar 5-fluorouracil also known as 5FU and leucovorin also known as LV Preclinical data from animal models suggest that the investigational drug may offer an effective means for preventing CPT-115FULV-induced diarrhea It is also hypothesized that the investigational drug-mediated anti-angiogenesis could induce a favorable tumor response
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