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Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Stage IV Colorectal Cancer, Gastric Cancer

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Trial Information

Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment

Outcome Description:

During the first cycle of treatment

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Authority:

Republic of Korea: Korea Food and Drug Administration (KFDA)

Study ID:

CPT_08_001

NCT ID:

NCT01271582

Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Stage IV Colorectal Cancer
  • Gastric Cancer
  • Colorecatal cancer
  • Gastric cancer
  • Irinotecan
  • UGT1A1
  • Neutropenia
  • Colorectal Neoplasms
  • Stomach Neoplasms

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