NCT01271582

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

5.4 years

First QC Date

January 4, 2011

Last Update Submit

January 27, 2019

Conditions

Stage IV Colorectal CancerGastric Cancer

Keywords

Colorecatal cancerGastric cancerIrinotecanUGT1A1Neutropenia

Outcome Measures

Primary Outcomes (1)

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

    During the first cycle of treatment

    2 weeks

Secondary Outcomes (3)

  • Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration

    24 weeks

  • Association between grade 3/4 diarrhea and UGT1A1 polymorphism

    2 weeks

  • Progression-free survival

    6 months (average)

Study Arms (1)

FOLFIRI

EXPERIMENTAL

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

Interventions

Irinotecan, 5FU, leucovorinDRUG

FOLFIRI regimen every 2 weeks \[irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)\]

Also known as: CAMPTO (CAMPOSAR)
FOLFIRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
  • 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)
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Location

Hwasun Hospital

Jeonam, Hwasun-gun, South Korea

Location

Korea Cancer Center Hospital

Seoul, Nowon-Gu, South Korea

Location

Asan Medical Center

Seoul, Songpa-Gu, 05505, South Korea

Location

National Cancer Center

Goyang, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsStomach NeoplasmsNeutropenia

Interventions

IrinotecanFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • YongSang Hong, Professor

    Asan Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 7, 2011

Study Start

January 1, 2009

Primary Completion

June 1, 2014

Study Completion

December 1, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

KR(5)