Colorectal Neoplasms Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically diagnosed unresectable or metastatic colorectal cancer - Performance status of 0, 1 and 2 on the ECOG criteria - Disease status must be that of measurable disease as defined by RECIST criteria (For genotype-PD study only) Only non-target lesions are allowed for PK study - No previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (For genotype-PD study only) Previously treated patients are allowed for PK study - Life expectancy of more than 3 months (For genotype-PD study only) - Adequate major organ functions - Compliant patient who can be followed-up adequately - Informed consent Exclusion Criteria: - Active or uncontrolled infection - Pregnant or breast-feeding women - Patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy - Patients with brain metastasis (For genotype-PD study only) - Patients treated with radiotherapy within 2 weeks (For genotype-PD study only) |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center Korea | Goyang | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SLCO1B1 and PXR genotypes and maximal response rate? | Before & during treatment | ||
Primary | SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38 | Before and 1st cycle | ||
Secondary | SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival |
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