PMID: 9435928Jan 22, 1998Paper

Pharmacokinetic and pharmacodynamic properties of docetaxel: results of phase I and phase II trials

American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
R BrunoL Thomas

Abstract

The pharmacokinetics of docetaxel as investigated in Phase I and Phase II trials are discussed. Phase I trials have shown that docetaxel exhibits linear pharmacokinetics consistent with a three-compartment model. Population pharmacokinetic and pharmacodynamic analysis of the results of 22 nonrandomized Phase II trials with nonlinear mixed-effects modeling showed that the interpatient variability of docetaxel pharmacokinetics is mainly related to body surface area and hepatic function. The effect of body surface area on clearance does not present a problem, since the dose of docetaxel is adjusted for body size. However, patients with impaired liver function are at increased risk of serious adverse effects (febrile neutropenia, severe infections, severe stomatitis, and toxic death) during treatment with docetaxel 100 mg/ m2. Patients with impaired liver function should receive a reduced dose (75 mg/m2). The presence of liver metastases without impaired liver function had no effect on docetaxel's clearance or safety, suggesting that a dose of 100 mg/m2 is well tolerated in such patients. Docetaxel pharmacokinetics and pharmacodynamics determined in Phase I and Phase II trials indicate a need to adjust the dosage for body surface a...Continue Reading

Citations

May 10, 2006·Investigational New Drugs·Basil F El-RayesPhilip A Philip
Dec 18, 2003·British Journal of Clinical Pharmacology·Kellie A SlavieroLaurent P Rivory
Mar 1, 2005·Basic & Clinical Pharmacology & Toxicology·Pascal Girard
Oct 10, 2006·Future Oncology·Peter C Thuss-PatiencePeter Reichardt
Oct 12, 2014·Cancer Chemotherapy and Pharmacology·Devalingam MahalingamAlain C Mita
Jan 10, 2017·The Korean Journal of Physiology & Pharmacology : Official Journal of the Korean Physiological Society and the Korean Society of Pharmacology·Jie WangYu Yu
Nov 5, 2015·Expert Opinion on Investigational Drugs·Costantine Albany, Guru Sonpavde
Oct 14, 2005·Journal of Pharmacokinetics and Pharmacodynamics·Ferdinand RomboutUNKNOWN COST B15 Experts
Nov 26, 2008·Magnetic Resonance in Medicine : Official Journal of the Society of Magnetic Resonance in Medicine·Anne M NeubauerSamuel A Wickline
Nov 5, 2010·Journal of Cardiovascular Magnetic Resonance : Official Journal of the Society for Cardiovascular Magnetic Resonance·Patrick M WinterSamuel A Wickline
Sep 27, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Charlotte KloftMats O Karlsson

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