Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
NCT ID: NCT00540982
Last Updated: 2025-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
47 participants
INTERVENTIONAL
1997-02-20
2010-05-20
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normal Liver Function
indocyanine green
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study
Determination of concentrations of vinorelbine and its metabolites
Mild Liver Dysfunction
indocyanine green
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study
Determination of concentrations of vinorelbine and its metabolites
Moderate Liver Dysfunction
indocyanine green
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study
Determination of concentrations of vinorelbine and its metabolites
Severe Liver Dysfunction
indocyanine green
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study
Determination of concentrations of vinorelbine and its metabolites
Interventions
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indocyanine green
0.5 mg/kg will be administered by IV push to determine clearance
lidocaine
1 mg/kg will be administered to determine metabolic capacity
vinorelbine ditartrate
Varying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function
high performance liquid chromatography
Used to determine plasma concentrations of vinorelbine
intracellular fluorescence polarization analysis
Used to determine concentration of lidocaine metabolic capacity
liquid chromatography
Used to determine concentrations of vinorelbine and its metabolites
mass spectrometry
Used to determine concentrations of vinorelbine and its metabolites
pharmacological study
Determination of concentrations of vinorelbine and its metabolites
Eligibility Criteria
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Inclusion Criteria
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent illness (e.g., cardiovascular, pulmonary, or central nervous system) that is poorly controlled or of such severity that the investigator deems unwise to enter the patient on protocol
* Must have ability to comply with study treatment and required tests
* Obstructive jaundice requires a drainage procedure prior to study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea therapy)
* No prior radiotherapy to \> 30% of the bone marrow or more than standard adjuvant pelvic radiotherapy for rectal cancer
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Joseph Chao
Role: STUDY_CHAIR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Countries
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Other Identifiers
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CHNMC-96032
Identifier Type: -
Identifier Source: secondary_id
CDR0000567457
Identifier Type: REGISTRY
Identifier Source: secondary_id
96032
Identifier Type: -
Identifier Source: org_study_id
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