Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction
- To correlate indocyanine green and lidocaine metabolism with vinorelbine ditartrate
pharmacokinetics in patients with advanced, refractory solid tumors and varying degrees
of liver dysfunction.
- To determine the pharmacokinetics of vinorelbine ditartrate in these patients.
- To test a plan of dose adjustment for vinorelbine ditartrate administration in these
OUTLINE: Patients are stratified according to extent of clinical liver dysfunction (normal
vs mild vs moderate vs severe).
Patients receive dose-adjusted vinorelbine ditartrate IV over 10 minutes once weekly in the
absence of disease progression or unacceptable toxicity. Patients achieving an objective
complete response receive 2 additional courses of study therapy.
Patients undergo blood sample collection periodically during study for pharmacokinetic and
pharmacodynamic correlative studies. Blood is also collected after patients receive
lidocaine IV push and indocyanine green (ICG) IV push. Samples are analyzed for whole blood
and plasma concentrations of vinorelbine ditartrate and its metabolites by high performance
liquid chromatography (15) or by liquid chromatography/tandem mass spectrometry assay.
Samples are also analyzed for ICG clearance and lidocaine hydrochloride metabolic capacity
by fluorescent polarization immunoassay.
After completion of study therapy, patients are followed periodically.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation of indocyanine green and lidocaine metabolism with vinorelbine ditartrate pharmacokinetics
2 months post treatment
Joseph Chao, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|City of Hope Medical Group||Pasadena, California 91105|