Colorectal NeoplasmsNCT00507143
Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan
A study testing irinotecan in people with Colorectal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Secondary
- What is being tested?
- irinotecan
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
Yong Sang Hong, M.D.
Hyeong-Seok Lim, M.D.
About this study
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.
Read the 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.
- Conditions
- Colorectal Neoplasms, Secondary
- Being tested
- irinotecan
- Keywords
- Colorectal neoplasms, Secondary, irinotecan, Pharmacokinetics, Pharmacodynamics, SLCO1B1, PXR
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
SLCO1B1 and PXR genotypes and maximal response rate
Measured: Before & during treatment
SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38
Measured: Before and 1st cycle
Secondary outcomes (1)
SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startAug 2006
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507143
- Sponsor's protocol ID
- NCCCTS-06-206
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00507143
- Acronym / sponsor ID
- NCCCTS-06-206
- Conditions
- Colorectal Neoplasms, Secondary
- Keywords
- Colorectal neoplasms, Secondary, irinotecan, Pharmacokinetics, Pharmacodynamics, SLCO1B1, PXR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irinotecan | Drug | – |
Primary outcome
SLCO1B1 and PXR genotypes and maximal response rate
Time frame: Before & during treatment
SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38
Time frame: Before and 1st cycle
1 secondary outcome
SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Hae Jung, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irinotecan in people with Colorectal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Hae Jung, M.D. (+82-31-920-1611, khjung@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLCO1B1 and PXR genotypes and maximal response rate (time frame: Before & during treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007.