Unique ID issued by UMIN | UMIN000004988 |
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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 |
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.
Pharmacokinetic analysis of carboplatin in cancer patients with severe renal insufficiency.
Japan |
advanced cancer with severe renal insufficiency
Pneumology | Nephrology | Chest surgery |
Obstetrics and Gynecology | Oto-rhino-laryngology | Orthopedics |
Urology |
Malignancy
NO
To establish the optimal dose of carboplatin in cancer patients with severe renal insufficiency.
Pharmacokinetics
Exploratory
Pragmatic
Not applicable
Safty
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom |
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
20 | years-old | <= |
Not applicable |
Male and Female
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
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
10
1st name | |
Middle name | |
Last name | Yuichi Ando |
Nagoya university hospital
Clinical oncology and chemotherapy
65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken
052-744-1903
yando@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Tomoyo Oguri |
Nagoya university hospital
Respiratory medicine
65 Tsurumai-cho Showa-ku Nagoya-shi Aichi-ken
052-744-2167
tomonet3@med.nagoya-u.ac.jp
Nagoya university hospital
none
Other
Nagoya university hospital, Department of Nephrology
Kumamoto university hospital, Department of
Pharmacy
NO
名古屋大学医学部附属病院(愛知県)
Nagoya university hospital(Aichi)
2011 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 01 | Month | 25 | Day |
2011 | Year | 02 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
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2013 | Year | 05 | Month | 01 | Day |
2011 | Year | 01 | Month | 31 | Day |
2014 | Year | 01 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005928
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