Clinical trial NCT01271582: Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stage IV Colorectal Cancer
Gastric Cancer
Keywords: Colorecatal cancer
Gastric cancer
Irinotecan
UGT1A1
Neutropenia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
timeFrame: 24 weeks
measure: Association between grade 3/4 diarrhea and UGT1A1 polymorphism
timeFrame: 2 weeks
measure: Progression-free survival
timeFrame: 6 months (average)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Chŏnam
country: Korea, Republic of
facility: Hwasun Hospital
state: Hwasun-gun
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
state: Nowon-Gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
Study officials:
affiliation: Asan Medical Center
name: YongSang Hong, Professor
role: STUDY_DIRECTOR
References: