Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Tae Won Kim, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT01271582

First received: January 4, 2011

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 4, 2011
Last Updated Date	July 16, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 6, 2011)	Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] During the first cycle of treatment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01271582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 6, 2011)	Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] During all treatment period(during 12 cycle, each 2 weeks) Association between grade 3/4 diarrhea and UGT1A1 polymorphism [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] During the first cycle of treatment Progression-free survival [ Time Frame: 6 months (average) ] [ Designated as safety issue: No ] The time from registration to objective tumor progression or death
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
Official Title ^ICMJE	Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Stage IV Colorectal Cancer Gastric Cancer
Intervention ^ICMJE	Drug: Irinotecan, 5FU, leucovorin 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)] Other Name: CAMPTO (CAMPOSAR)
Study Arm (s)	Experimental: FOLFIRI Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI regimen upto 12 cycles. (Single arm study) Intervention: Drug: Irinotecan, 5FU, leucovorin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	1500
Estimated Completion Date	December 2013
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01271582
Other Study ID Numbers ^ICMJE	CPT_08_001
Has Data Monitoring Committee	No
Responsible Party	Tae Won Kim, Asan Medical Center
Study Sponsor ^ICMJE	Asan Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asan Medical Center
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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