UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005363 |
|---|---|
| Receipt number | 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 14:57:07 |
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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
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
tshibata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006364
