Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396487
Status:
TERMINATED
Last Update Posted:
2015-06-11
First Post:
2006-11-06
Brief Title:
Tailored Treatment in Metastatic Colorectal Cancer
Sponsor:
Vejle Hospital
Organization:
Vejle Hospital
Study Overview
Official Title:
Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only one patient included as per Feb 4 2008
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial
Detailed Description:
The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue The results indicated that protein with a 33 TS polymorphism or a MTHFR T polymorphism had a significantly higher response rate and a longer time to progression than the other groups when treated with bolus 5-FU
Capecitabine is metabolised to 5-FU through a number of enzymatic steps It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase TP in many human tumors compared to normal tissue TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU A number of small investigations have indicated that patients with 2R2R TS polymorphism have a higher response rate than heterozygous patients
The TS and MTHFR polymorphism analysis can easily be performed on sputum which means an easy collection and sending of the samples
At present single agent chemotherapy is based on three drugs 5-FU capecitabine and Irinotecan with almost the same overall activity It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism
Capecitabine is metabolised to 5-FU through a number of enzymatic steps It is the first rationally designed drug that is based upon the high concentration of thymidine phosphorylase TP in many human tumors compared to normal tissue TP is the last step in the conversion of capecitabine to 5-FU and seems to be the limiting factor for the activation Capecitabine may to some extent mimic continues 5-FU infusion as opposed to bolus 5-FU A number of small investigations have indicated that patients with 2R2R TS polymorphism have a higher response rate than heterozygous patients
The TS and MTHFR polymorphism analysis can easily be performed on sputum which means an easy collection and sending of the samples
At present single agent chemotherapy is based on three drugs 5-FU capecitabine and Irinotecan with almost the same overall activity It seems rational to investigate if improvement can be obtained by tailoring the treatment according to gene polymorphism
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