CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
indocyanine green +7 moredrug
Likely dose
indocyanine green 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00540982
NCT00540982Phase 2Completed
CompareCT.gov

Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction

City of Hope Medical Center·interventional·Posted Oct 8, 2007·Updated Jul 2, 2025

In Brief

A Phase 2 clinical trial evaluating indocyanine green, lidocaine, and 6 other interventions for Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific. Completed, enrolled 47 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2007
Enrollment StartFeb 20, 1997
Primary CompletionMay 20, 2010
TodayJul 2, 2026
Enrollment to primary: 13.3 yearsPosted 18.7 years ago

Interventions

indocyanine greendrug

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

lidocainedrug

1 mg/kg will be administered to determine metabolic capacity

vinorelbine ditartratedrug

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

high performance liquid chromatographyother

Used to determine plasma concentrations of vinorelbine

intracellular fluorescence polarization analysisother

Used to determine concentration of lidocaine metabolic capacity

liquid chromatographyother

Used to determine concentrations of vinorelbine and its metabolites

mass spectrometryother

Used to determine concentrations of vinorelbine and its metabolites

pharmacological studyother

Determination of concentrations of vinorelbine and its metabolites