Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan
Recruitment status was Recruiting
|First Received Date ICMJE||July 23, 2007|
|Last Updated Date||July 23, 2007|
|Start Date ICMJE||August 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan|
|Official Title ICMJE||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|
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.
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), 0.75 h, 1.5 h and each at time ranges of 2~8 h, 8~16 h, 24~32h and 48~52 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 48~52 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 3.0.
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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Intervention ICMJE||Drug: irinotecan|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||December 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Korea, Republic of|
|NCT Number ICMJE||NCT00507143|
|Other Study ID Numbers ICMJE||NCCCTS-06-206|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Center, Korea|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Center, Korea|
|Verification Date||July 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP