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

NCT ID: NCT00507143

Last Updated: 2007-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Neoplasms Secondary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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irinotecan

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Kyung Hae Jung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Hae Jung, M.D.

Role: CONTACT

[email protected]
+82-31-920-1611

Eun Kyung Shim

Role: CONTACT

[email protected]
+82-31-920-1145

Other Identifiers

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NCCCTS-06-206

Identifier Type: -

Identifier Source: org_study_id