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

Part of paid clinical trials in Duarte, California.

Sponsor: City of Hope Medical Center
Study ID: NCT00540982
Phase: PHASE1/PHASE2
Status: Completed

Conditions

Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex: ALL
Age: 18 Years - 120 Years
Healthy Volunteers: Not accepted

Interventions

indocyanine green — DRUG
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine — DRUG
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate — DRUG
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography — OTHER
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis — OTHER
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography — OTHER
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry — OTHER
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study — OTHER
Determination of concentrations of vinorelbine and its metabolites

Study Details

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.