Cancer Clinical Trial
Official title:
Pharmacokinetics of Carboplatin After Adjusted Dosing for High BMI, Low Serum Creatinine, and Maximal Renal Function
An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care.
Carboplatin is an alkylating anticancer drug that is used for the treatment of various types
of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC),
malignant mesothelioma, ovarian cancer, and breast cancer. It is mostly given in combination
with other chemotherapeutic drugs, but it can also be given as single agent.
Since carboplatin is highly eliminated by the kidneys, the dose needs to be adjusted for
renal dysfunction. Furthermore, as there is clear correlation between the area under the
concentration-time curve (AUC) of carboplatin and haematological toxicity and response rate,
carboplatin is dosed per target AUC. For this, the standard pharmacokinetic formula [dose =
clearance carboplatin x target AUC] is used.
the clearance is typically calculated using the cockcroft and gault (C-G) formula. In
patients with high weight, or very low serum creatinine values the C-G-formula may
overestimate the renal function, resulting in a potential overdose of carboplatin. the new
developed dosing algorithm to be studied adjusts for high BMI and low serum creatinine
values, in order to provide a more safe dose of carboplatin
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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