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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005363
Receipt No. R000006364
Scientific Title Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction
Date of disclosure of the study information 2011/04/01
Last modified on 2013/03/01

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Basic information
Public title Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction
Acronym Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction
Scientific Title Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction
Scientific Title:Acronym Clinical dose-finding and pharmacokinetic study of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction
Region
Japan

Condition
Condition biliary tract cancer or pancreatic cancer with liver dysfunction
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to determine the optimal dose of gemcitabine in patients with biliary tract or pancreatic cancer with liver dysfunction. In addition, we measure plasma concentrations of unchanged gemcitabine and its metabolism (2'-deoxy-2',2' difluorouridine: dFdU) using high-performance liquid chromatography, and we consider the pharmacokinetics.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Performance status, hematologic toxicity, and non-hematological toxicity during the first course of gemcitabine
Key secondary outcomes Pharmacokinetics

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are classified into three groups ; mild, moderate or severe liver dysfunction. Determination of the optimal dose for each group.
1) Mild dysfunction;
Group1 Total bilirubin =<ULN,
AST/ALT>ULN
Group2 Total bilirubin >1.0x to 1.5x
ULN, AST/ALT Any
2) Level1;1000mg/m2
3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics
Interventions/Control_2 1) Moderate dysfunction;
Total bilirubin >1.5x to 3.0x ULN,
AST/ALT Any
2) Level1;800mg/m2, Level2;1000mg/m2
3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics
Interventions/Control_3 1) Severe dysfunction;
Total bilirubin >3.0x to 10x ULN,
AST/ALT Any
2) Level1;800mg/m2, Level2;1000mg/m2
Level-1;650mg/m2
3) blood samples (8 points) are collected bofore and after the first administration of gemcitabine to consider its pharmacokinetics
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cytologically or histologically diagnosed biliary tract or pancreatic cancer
2) planned to receive gemcitabine monotherapy (including adjuvant chemotherapy)
3) Patients with liver dysfunction
4) Patients over 20 years old at the time of obtaining informed consent
5) Performance status 0-2 in classification of mild or moderate liver dysfunction
Performance status 0,1 in classification of severe liver dysfunction
6) Patients with adequate bone marrow functions
neutrophil count >= 1,500/uL
platelet count >= 10,0000/uL
hemoglobin >= 9.0g/dL
7) Patients received a sufficient explanation for this study and agreed
8) does not ask whether the patients have the mesurable lesion
9) If the patient underwent biliary drainage,the patient met the above criteria can be incorporated
Key exclusion criteria 1) Patients have received in the past gemcitabine hydrochloride monotherapy
2) Total bilirubin >10x ULN
3) Serum creatinin >1.5x ULN
4) Performance status 2 in classification of severe liver dysfunction
5) patients with interstitial pneumonia or pulmonary fibrosis on chest X-ray and having clinical symptoms
6) Patients with infections requiring treatment
7) Patients with uncontrolled diabetes despite the enforcement of appropriate drug therapy (including insulin)
8) it is clear that patients with constitutional jaundice
9) HBc antibody, HCV antibody, HIV antibody or syphilis positive
10) In addition, patients were judged inappropriate to participate in the clinical trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ando
Organization Nagoya university hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya-shi,Aichi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Shibata
Organization Nagoya university hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address
TEL
Homepage URL
Email tshibata@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya university hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya university, Department of Surgical Oncology
Saitama medical university, Department of Clinical Oncology
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 名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
2011 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2013 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006364

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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