Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Study of 5-fluorouracil 5-FU in Patients With Metastatic Colorectal Cancer
Sponsor:
Inova Health Care Services
Organization:
Inova Health Care Services
Study Overview
Official Title:
A Pilot Study of Pharmacokinetically PK Dose Adjusted 5-Fluorouracil 5-FU in Patients With Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer
Detailed Description:
5-fluorouracil 5-FU has been the most widely used agent in the treatment of early stage and advanced colorectal cancer Traditionally 5-FU dosing is based on body surface area BSA However BSA-dosing has been associated with a wide range of pharmacokinetic PK variability resulting in marked differences in drug exposure and toxicities in an individual There is a significant association between the risk of 5-FU-related toxicities and the extent of 5- FU systemic exposure which can be measured using a well-established pharmacokinetic PK assay
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