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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004988

Enrollment

Registered

2011-02-01

Start date

2011-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced cancer with severe renal insufficiency

Interventions

1)The dose of carboplatin is determined using the Calvert formula 2)For patients who don&#39

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 pha

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safty	—

Countries

Japan

Contacts

Public ContactTomoyo Oguri

Nagoya university hospital Respiratory medicine

tomonet3@med.nagoya-u.ac.jp052-744-2167

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026