The study aims to assess the pharmacokinetics of paclitaxel and its two major metabolites in patients with normal and impaired liver functions.
population pharmacokinetic study in patients with normal or impaired liver functions, receiving paclitaxel for cancer treatment. 40 Patients with histologically confirmed solid tumors will be enrolled in the study: * 20 patients have normal liver functions as defined by transaminase \< 2.6 x ULN and bilirubin values \< 1.26 x ULN. * 20 patients with liver impairment as defined by transaminase 2.6 - 10 x ULN and bilirubin values 1.26 - 5 x ULN.
Study Type
OBSERVATIONAL
Enrollment
40
Plasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion.
El Demerdash Oncology Hospital
Cairo, Abbasia, Egypt
RECRUITINGplasma concentrations of paclitaxel
determination of plasma concentration and pharmacokinetic analysis of paclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
plasma concentrations of 6-α-hydroxypaclitaxel
determination of plasma concentration and pharmacokinetic analysis of 6-α-hydroxypaclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
plasma concentrations of 3'-p-hydroxypaclitaxel
determination of plasma concentration and pharmacokinetic analysis of 3'-p-hydroxypaclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
Probing CYP 3A4 activity
metabolite ratio of 6-α-hydroxypaclitaxel/paclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
Probing CYP 2C8 activity
metabolite ratio of 3'-p-hydroxypaclitaxel/paclitaxel
Time frame: predose till 6 hours post infusion of paclitaxel
Incidence of adverse effects
Complete blood count, liver functions and neuropathy evaluation (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5) will be assessed
Time frame: baseline ( before first dose) till 100 days after the first dose
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