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

NCT00507143 | Unknown

• 1 other identifier: NCCCTS-06-206
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasms; Secondary

Keywords

Colorectal neoplasms; Secondary; irinotecan; Pharmacokinetics; Pharmacodynamics; SLCO1B1; PXR

Outcome Measures

Primary Outcomes (2)

• SLCO1B1 and PXR genotypes and maximal response rate

  Before & during treatment

• SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38

  Before and 1st cycle

Secondary Outcomes (1)

• SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival

Interventions

irinotecan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Kyung Hae Jung, M.D.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hae Jung, M.D.

CONTACT

+82-31-920-1611; khjung@ncc.re.kr

Eun Kyung Shim

CONTACT

+82-31-920-1145; ncccoloonco@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: August 1, 2006
• Study Completion: December 1, 2008
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

KR (1)