Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507143
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-23
Brief Title:
Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Clinical Study for the Evaluation of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on the Pharmacokinetics and Treatment Effects of Irinotecan in Patients With Colorectal and Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
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:
From 100 colorectal cancer patients being treated with FOLFIRI regimen or any kind of irinotecan containing regimen blood samples for irinotecan and its metabolites levels and genotypes related with its metabolism will be collected The association of their levels and genotypes and treatment effects will be evaluated
Detailed Description:
For the genotype-PD association 50 colorectal cancer patients treated with FOLFIRI will be enrolled and studied 50 additional colorectal patients treated with any kind of irinotecan containing regimen will be enrolled and including the 50 patients for the genotype-PD association a total of 100 patients will be evaluated for the genotype-PK association
Blood samples for PK analysis will be collected from patients with colorectal cancer during 1st treatment cycle of irinotecan and 2nd 3rd infusion During the 1st treatment cycle blood will be drawn 0 h before irinotecan infusion 075 h 15 h and each at time ranges of 28 h 816 h 2432h and 4852 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 4852 hours after the respective 2nd and 3rd infusion
For 50 colorectal cancer patient treated with FOLFIRI regimen responses to the treatment will be assessed every 3 cycles All assessments will be repeated at the end of trial therapy
The RECIST criteria for measurable disease will be followed and toxicity will be evaluated according to NCI common toxicity criteria version 30
Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression
Blood samples for PK analysis will be collected from patients with colorectal cancer during 1st treatment cycle of irinotecan and 2nd 3rd infusion During the 1st treatment cycle blood will be drawn 0 h before irinotecan infusion 075 h 15 h and each at time ranges of 28 h 816 h 2432h and 4852 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 4852 hours after the respective 2nd and 3rd infusion
For 50 colorectal cancer patient treated with FOLFIRI regimen responses to the treatment will be assessed every 3 cycles All assessments will be repeated at the end of trial therapy
The RECIST criteria for measurable disease will be followed and toxicity will be evaluated according to NCI common toxicity criteria version 30
Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression
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