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

Summary

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.

Conditions

• Lung Cancer
• Unspecified 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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Joseph Chao · City of Hope Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1997-02-20

Primary Completion

2010-05-20

Completion

2010-05-20

Countries

• United States

Study Locations