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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004773
Receipt No. R000005625
Scientific Title A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.
Date of disclosure of the study information 2010/12/22
Last modified on 2010/12/22

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Basic information
Public title A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.
Acronym Feasibility study of Irinotecan(CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.
Scientific Title A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.
Scientific Title:Acronym Feasibility study of Irinotecan(CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To estimate safety for bi-weekly FOLFIRI(+BV) therapy by the groups of UGT1A1 gene polymorhisms in patients with metastatic colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1)incidence of adverse events
2)frequency of severe toxicity

Key secondary outcomes 1)response rate
2)time to treatment failure
3)progression free survival
4)overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive FOLFIRI with bevacizumab fixed 5mg/kg. (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.)
Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation.
CPT-11 dosage is
wild and heterozygous:CPT-11 150mg/m2
homozygous:CPT-11 100mg/m2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed colorectal cancer
2) Metastatic colorectal cancer
3) FOLFOX(+BV) or XELOX(+BV) treatment failure
4) Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms
5) Wash out:>=14 days for operation, and >=21 days for chemotherapy and/or radiotherapy
6) No prior irinotecan containing treatment
7) PS(ECOG):0 to 1
8) A life expectancy for at least 2 months
9) Aduquate main organ (bone marrow, heart, pulumonary, liver, renal) function

WBC 3,000-12,000/mm3,
Neutrophil >=1500/mm3
Platelet >=100,000/mm3
Hb >=8.5mg/dL
AST(GOT) <=100IU/L
ALT(GPT)<=100IU/L
T-bilirubin <=2.0mg/dL
serum creatinine <=1.50mg/dL
10) Written informed consent
Key exclusion criteria 1)History of serious drug allergy
2)Active concomitant malignancy
3)Prior extensively irradiation for abdominal or bowel bone marrow
4)Symptomatic brain metastasis
5)Systemic continual use of steroids
6)Active infection
7)Persistent diarrhea (watery stool)
8)Intestinal obstraction or paralytic ileus
9)Interstitial pneumonia or pulmonary fibrosis
10)Massive pleural, pericardial effusion or asites that required drainage
11)Need to treatment with atazanavir sulfate
12)maintained phenytoin or warfarin
13)Uncontrolled diabetes mellitus
14)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment
15)Psychological disease deemed to unacceptable for inclusion to the study
16)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy
17)Other concominant medical condition deemed to inadequate for inclusion to the study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Shimada
Organization Institute of Health Biosciences,
The University of Tokushima Graduate School
Division name Department of Digestive and Pediatric Surgery
Zip code
Address 18-15 Kuramotocho 3-chome, Tokushima city
TEL 088-633-7139
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Nishioka
Organization The University of Tokushima Graduate School
Division name Department of Digestive and Pediatric Surgery
Zip code
Address 18-15 Kuramotocho 3-chome, Tokushima city
TEL 088-633-7139
Homepage URL
Email

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2008 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 22 Day
Last modified on
2010 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005625

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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