Stage IV Colorectal CancerPhase 4NCT01271582
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
A Phase 4 study testing Irinotecan, 5FU, leucovorin in people with Stage IV Colorectal Cancer and Gastric Cancer, run by Asan Medical Center at 5 sites in South Korea.
Trial summary
The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Colorectal Cancer, Gastric Cancer
- What is being tested?
- Irinotecan, 5FU, leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jan 2009to Dec 2019
- Phase
- Phase 4
- 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
Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial.
- Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy
- Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.
- Aged 18 years or older.
- ECOG performance status of ≤ 2.
- Anticipated life expectancy of ≥ 3 months.
- Clinically acceptable function of bone marrow, kidney and liver function as below.
- ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
- Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
- Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min
- Subjects whose written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial.
- Pregnant or breast feeding women
- Serious concurrent complication, severe active infection.
- Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis
- Subjects with epilepsia or severe psychiatric disorders.
- Subjects who are regarded to be unsuitable for this trial by the investigator.
- Subjects who are participating in other clinical trials
- Subjects who have received prior chemotherapy including irinotecan.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
National Cancer Center
Goyang
Hwasun Hospital
Jeonam, Hwasun-gun
Samsung Medical Center
Seoul, Gangnam-gu
Korea Cancer Center Hospital
Seoul, Nowon-Gu
Asan Medical Center
Seoul, Songpa-Gu, 05505
About this study
Official title: Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.
- Conditions
- Stage IV Colorectal Cancer, Gastric Cancer
- Being tested
- Irinotecan, 5FU, leucovorin
- Keywords
- Colorecatal cancer, Gastric cancer, Irinotecan, UGT1A1, Neutropenia
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, 5FU, leucovorinDrug
Also called CAMPTO (CAMPOSAR)
FOLFIRI regimen every 2 weeks [irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)]
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Experimental | Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study) Receives: Drug: Irinotecan, 5FU, leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
During the first cycle of treatment
Measured: 2 weeks
Secondary outcomes (3)
Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
During all treatment period(during 12 cycle, each 2 weeks)
Measured: 24 weeks
Association between grade 3/4 diarrhea and UGT1A1 polymorphism
During the first cycle of treatment
Measured: 2 weeks
Progression-free survival
The time from registration to objective tumor progression or death
Measured: 6 months (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2009
- Primary completionJun 2014
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Won Kim, Asan Medical Center
- Investigators
- YongSang Hong, Professor, Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271582
- Sponsor's protocol ID
- CPT_08_001
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2011
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
- ClinicalTrials.gov ID
- NCT01271582
- Acronym / sponsor ID
- CPT_08_001
- Conditions
- Stage IV Colorectal Cancer, Gastric Cancer
- Keywords
- Colorecatal cancer, Gastric cancer, Irinotecan, UGT1A1, Neutropenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jan 2011 (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.
The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI | Experimental | Drug: Irinotecan, 5FU, leucovorinPatients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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, 5FU, leucovorinAlso: CAMPTO (CAMPOSAR)FOLFIRI regimen every 2 weeks [irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)] | Drug | FOLFIRI |
Primary outcome
Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
Time frame: 2 weeks
During the first cycle of treatment
3 secondary outcomes
Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
Time frame: 24 weeks
Association between grade 3/4 diarrhea and UGT1A1 polymorphism
Time frame: 2 weeks
Progression-free survival
Time frame: 6 months (average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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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.
YongSang Hong, Professor study director
Asan Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan, 5FU, leucovorin in people with Stage IV Colorectal Cancer and Gastric Cancer, run by Asan Medical Center at 5 sites 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?
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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment (time frame: 2 weeks). 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 29 Jan 2019.