UMIN-CTR Clinical Trial

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
Email	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
Email	hy0522@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002085

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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