UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001733 |
|---|---|
| Receipt number | R000002085 |
| Scientific Title | Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study |
| Date of disclosure of the study information | 2009/02/26 |
| Last modified on | 2016/03/28 20:33:29 |
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Basic information
Public title
Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study
Acronym
Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study
Scientific Title
Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study
Scientific Title:Acronym
Pharmacokinetic and clinical analysis of combination chemotherapy with cisplatin and irinotecan in lung cancer patients undergoing hemodialysis: A phase I study
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To analyze pharmacokinetic parameters, and to investigate recommended dose and feasibility of combined Cx with CDDP and CPT-11 in lung cancer patients with chronic renal failure undergoing HD.
Key secondary outcomes
To evaluate feasibility and toxicity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CDDP 60 mg/m2 day-1 (0.5-h infusion)
CPT-11 30 to 60 mg/m2 day-1, 8, 15 (1.5-h infusion)
HD was started immediately after completing the administration of CPT-11, and the chemotherapy was repeated every 4 weeks.
The dose of CPT-11 was escalated by 10mg/m2 increment course-by-course within every patient.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included histologically or cytologically confirmed lung cancer and renal insufficiency undergoing HD, no prior chemotherapy,life expectancy of at least 3 months, age of 20-74 years, PS of 0,1 or 2 according to the European Cooperative Oncology Group scale, the presence of measurable or evaluable disease, adequate functional indices for bone marrow leucocyte or granulocyte count >4x109/l or 2x109, PLT count100x109/l, hemoglobin concentration>9g/dl, AST ALT<100IU/l, serum bilirubin>2.0g/dl), no medical problems severe enough to prevent compliance with the protocol.
Key exclusion criteria
Patients with other concurrent malignancies, active infections, pulmonary fibrosis, uncontrolled massive pleural effusion or ascites, significant cardiovascular diseases, or symptomatic metastasis to the brain, pregnancy or breast-feeding were excluded.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience medical research center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience medical research center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
Niigata Lung Cancer Treatment Group
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
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
新潟大学医歯学総合病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2005 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002085
