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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01271582
Recruitment Status : Active, not recruiting
First Posted : January 7, 2011
Last Update Posted : January 11, 2018
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Stage IV Colorectal Cancer Gastric Cancer Drug: Irinotecan, 5FU, leucovorin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
Study Start Date : January 2009
Primary Completion Date : June 2014
Estimated Study Completion Date : December 2018

Arms and Interventions

Arm Intervention/treatment
Experimental: FOLFIRI
Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)
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)]

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration [ Time Frame: 24 weeks ]
    During all treatment period(during 12 cycle, each 2 weeks)

  2. Association between grade 3/4 diarrhea and UGT1A1 polymorphism [ Time Frame: 2 weeks ]
    During the first cycle of treatment

  3. Progression-free survival [ Time Frame: 6 months (average) ]
    The time from registration to objective tumor progression or death

Eligibility Criteria

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

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.

    1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
    2. 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)
    3. 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.
Contacts and Locations

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): NCT01271582

Korea, Republic of
Samsung Medical Center
Seoul, Gangnam-gu, Korea, Republic of
Hwasun Hospital
Chŏnam, Hwasun-gun, Korea, Republic of
Korea Cancer Center Hospital
Seoul, Nowon-Gu, Korea, Republic of
Asan Medical Center
Seoul, Songpa-Gu, Korea, Republic of, 05505
National Cancer Center
Goyang, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Study Director: YongSang Hong, Professor Asan Medical Center
More Information

Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01271582     History of Changes
Other Study ID Numbers: CPT_08_001
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Tae Won Kim, Asan Medical Center:
Colorecatal cancer
Gastric cancer

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