Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

February 20, 1997

Primary Completion Date

May 20, 2010

Study Completion Date

May 20, 2010

Conditions
Lung CancerUnspecified Adult Solid Tumor, Protocol Specific
Interventions
DRUG

indocyanine green

0.5 mg/kg will be administered by IV push to determine clearance

DRUG

lidocaine

1 mg/kg will be administered to determine metabolic capacity

DRUG

vinorelbine ditartrate

Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function

OTHER

high performance liquid chromatography

Used to determine plasma concentrations of vinorelbine

OTHER

intracellular fluorescence polarization analysis

Used to determine concentration of lidocaine metabolic capacity

OTHER

liquid chromatography

Used to determine concentrations of vinorelbine and its metabolites

OTHER

mass spectrometry

Used to determine concentrations of vinorelbine and its metabolites

OTHER

pharmacological study

Determination of concentrations of vinorelbine and its metabolites

Trial Locations (2)

91105

City of Hope Medical Group, Pasadena

91010-3000

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER

NCT00540982 - Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction | Biotech Hunter | Biotech Hunter