Trial Information

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

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.