PHARMACOKINETICS OF CARBOPLATIN AFTER ADJUSTED DOSING FOR HIGH BMI, LOW SERUM CREATININE, AND MAXIMAL RENAL FUNCTION - CARBMI

rijnstate hospital, the netherlands0 个研究点开始时间: 2014年5月14日最近更新: 2014年10月27日

试验速览

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•-histologically or cytologically proven advanced NSCLC, SCLC or ovarian cancer
•-to be treated with carboplatin with a target AUC of 4, 5 or 6
•-age 18 years or older
•-WHO performance status 0 – 2
•-adequate bone marrow and liver function defined as
•ohaemoglobin = 6.0 mmol/L
•owhite blood cell count = 3.0 * 109/L
•oabsolute neutrophil count (ANC) = 1.5 * 109/L
•oplatelets = 100/L
•obilirubin = 1.5 times ULN
•oALAT and ASAT = 2.5 times ULN (in case of liver metastases = 5.0 times ULN).
•-estimated life expectancy of at least 12 weeks
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•Female patients should not be pregnant or breast-feeding. Female patients with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs.
•-Treatment with carboplatin with a target AUC of <4
•-active clinically serious infection
•-history of a kidney allograft
•-patients not suitable for follow-up

发起方

rijnstate hospital, the netherlands