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 17, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Stage IV Colorectal Cancer
Gastric Cancer
Drug: Irinotecan, 5FU, leucovorin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1500
Study Start Date: January 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRI
Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI 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)]
Other Name: CAMPTO (CAMPOSAR)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271582

Locations
Korea, Republic of
Hwasun Hospital
Hwasun-gun, Chunnam, Korea, Republic of
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of
Korea Cancer Center Hospital
Nowon-Gu, Seoul, Korea, Republic of
Asan Medical Center
Songpa-Gu, Seoul, Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
  More Information

No publications provided

Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01271582     History of Changes
Other Study ID Numbers: CPT_08_001
Study First Received: January 4, 2011
Last Updated: July 17, 2014
Health Authority: Republic of Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Colorecatal cancer
Gastric cancer
Irinotecan
UGT1A1
Neutropenia

Additional relevant MeSH terms:
Colorectal Neoplasms
Stomach Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Stomach Diseases
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014