UMIN-CTR Clinical Trial

Public title

Effects of severe renal failure on the pharmacokinetics of irinotecan and its metabolite, and adverse drug events

Acronym

Relation between irinotecan pharmacokinetics and severe renal failure

Scientific Title

Effects of severe renal failure on the pharmacokinetics of irinotecan and its metabolite, and adverse drug events

Scientific Title:Acronym

Relation between irinotecan pharmacokinetics and severe renal failure

Region

Japan

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

In this prospective study, we examined the effects of severe renal failure on the pharmacokinetics of irinotecan, SN-38, and SN-38G. Pharmacokinetics in cancer patients with severe renal failure associated with a Ccr of <20 mL/min who were undergoing dialysis were compared with those in patients with normal renal function (Ccr, >60 mL/min). We enrolled patients with UGT1A1*1/*1, *1/*6, or *1/*28 to ensure that the genetic backgrounds of UGT1A1 were similar.

Basic objectives2

PK,PD

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Ralation between renal function and irinotecan pharmacokinetics and adverse events

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. All patients had metastatic/recurrent, histologically confirmed solid tumors.
2. Patients did not receive irinotecan containing chemotherapy.
3. Eastern Cooperative Oncology Group performance status of 0 to 2.
4. Each patient was confirmed to have adequate bone marrow function (neutrocyte count, at least 1.5 x 109/L; platelet count, at least 100 x 109/L), liver function (serum bilirubin level, less than 1.5 mg/dL; transaminases, less than 2.0 times the upper limit of normal).
5. All patients signed a written informed consent form, granting permission for their peripheral blood samples and medical information to be used for research purposes.

Key exclusion criteria

1. Patients who prohibited to receive irinotecan.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yasutsuna Sasaki

Organization

Saitama Medical University

Division name

Department of Medical Oncology

Zip code

Address

1397-1, Yamane, Hidaka city, Saitama

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical University

Division name

Department of Medical Oncology

Zip code

Address

TEL

Homepage URL

Email

Institute

Saitama Medical University, Department of Medical Oncology

Institute

Department

Personal name

Organization

Saitama Medical University, Department of Medical Oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

05

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2004

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2005

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

All patients received irinotecan as monotherapy. Irinotecan was given at a dose of 100 mg/m2, either weekly for the first 3 weeks of a 4-week cycle or every 2 weeks. In every 2 weeks regimen, this lower dose of 100 mg/m2 was used instead of 150 mg/m2 at the discretion of the attending physician. All patients were divided into two groups: those with a Ccr calculated by the Cockcroft-Gault equation of 60 mL/min or higher and those with a Ccr of 20 mL/min or less who were receiving dialysis. The effects of severe renal failure on the pharmacokinetics of irinotecan, SN-38, and SN-38G were examined. Patients with UGT1A1*1/*1, *1/*6, or *1/*28 genotypes were included to ensure that the genetic backgrounds of UGT1A1 were similar.

Registered date

2010

Year

05

Month

12

Day

Last modified on

2011

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004371