Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Camptothecin; Irinotecan

Criteria

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)