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

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ClinicalTrials.gov Identifier: NCT00507143
Recruitment Status : Unknown
Verified July 2007 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
Sponsor:
Information provided by:
National Cancer Center, Korea

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Secondary Drug: irinotecan Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : August 2006
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. SLCO1B1 and PXR genotypes and maximal response rate [ Time Frame: Before & during treatment ]
  2. SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38 [ Time Frame: Before and 1st cycle ]

Secondary Outcome Measures :
  1. SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507143


Contacts
Contact: Kyung Hae Jung, M.D. +82-31-920-1611 khjung@ncc.re.kr
Contact: Eun Kyung Shim +82-31-920-1145 ncccoloonco@hanmail.net

Locations
Korea, Republic of
National Cancer Center Korea Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sub-Investigator: Yong Sang Hong, M.D.         
Sub-Investigator: Hyeong-Seok Lim, M.D.         
Sub-Investigator: Sun Young Kim, M.D.         
Sub-Investigator: Hye Suk Han, M.D.         
Sub-Investigator: Sun Lim         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Kyung Hae Jung, M.D.

ClinicalTrials.gov Identifier: NCT00507143     History of Changes
Other Study ID Numbers: NCCCTS-06-206
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007

Keywords provided by National Cancer Center, Korea:
Colorectal neoplasms
Secondary
irinotecan
Pharmacokinetics
Pharmacodynamics
SLCO1B1
PXR

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action