UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004988
Receipt number R000005928
Scientific Title Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Date of disclosure of the study information 2011/02/01
Last modified on 2014/01/31 11:47:50

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Basic information

Public title

Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.

Acronym

Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.

Scientific Title

Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.

Scientific Title:Acronym

Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.

Region

Japan


Condition

Condition

advanced cancer with severe renal insufficiency

Classification by specialty

Pneumology Nephrology Chest surgery
Obstetrics and Gynecology Oto-rhino-laryngology Orthopedics
Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To establish the optimal dose of carboplatin in cancer patients with severe renal insufficiency.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Safty

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

1)The dose of carboplatin is determined using the Calvert formula
2)For patients who don't undergo hemodialysis, the accurate GFR is estimated on the basis of inulin clearance
3)Blood samples (10 to 11 points)are collected after the first administration of carboplatin to study of its pharmacokinetics

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven advanced cancer
2) Age>=20years
3) Planned to receive carboplatin chemotherapy which is monotherapy or is combined paclitaxel, docetaxel,gemcitabine,etoposide and irinotecan
4) Severe renal insufficiency: eGFR<30mL/min/1.73m2, including patients who undergo hemodialysis
5) No chemotherapy with any antineoplastic agents within the past 4 weeks
Patients who recieved cisplatin based chemotherapy within the past 12 weeks are ineligible
6) ECOG PS:0-2
7) It doesn't asked patients have mesurabel lesion or not
8 )Adequate organ function except renal function
white-cell count>= 3,000/uL
platelet count>= 100,000/uL
hemoglobin concentration >= 9.0g/uL
AST/ALT<= 3x institutional upper limit of normal
Total bilirubin<= 1.5 x institutional upper limit of normal
9)Written informed consent
10)Life expectancy more than 2 months

Key exclusion criteria

1)Accumulation of coelomic fluid (e.g.,pleural effusion,ascites fluid)requiring regular drainage and/or any other surgical intervention during the trial
2)Patients with clinically significant serious infectious disease at the time of screening
3)Patient is judged by investigator to be inappropriate for study participation for serious psychiatric condition
4)Patient is judged by investigator to be inappropriate for study participation for any reason

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichi Ando

Organization

Nagoya university hospital

Division name

Clinical oncology and chemotherapy

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken

TEL

052-744-1903

Email

yando@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyo Oguri

Organization

Nagoya university hospital

Division name

Respiratory medicine

Zip code


Address

65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken

TEL

052-744-2167

Homepage URL


Email

tomonet3@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 hospital, Department of Nephrology
Kumamoto university hospital, Department of
Pharmacy

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(愛知県)
Nagoya university hospital(Aichi)


Other administrative information

Date of disclosure of the study information

2011 Year 02 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 01 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 01 Day

Date trial data considered complete

2013 Year 04 Month 01 Day

Date analysis concluded

2013 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 01 Month 31 Day

Last modified on

2014 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005928


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name