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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

January 4, 2011
July 17, 2014
January 2009
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01271582 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage IV Colorectal Cancer
  • Gastric Cancer
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)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
July 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01271582
CPT_08_001
No
Tae Won Kim, Asan Medical Center
Asan Medical Center
Not Provided
Not Provided
Asan Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP