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

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 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


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

Value
https://center6.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