Lung Cancer Clinical Trial
Official title:
Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This pilot trial is studying the side effects and best dose of vinorelbine in
treating patients with advanced solid tumors that have not responded to treatment and liver
dysfunction.
OBJECTIVES:
- 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
patients.
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.
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