Lung CancerPhase 1/2NCT00540982
Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
A Phase 1/2 study testing indocyanine green, lidocaine and vinorelbine ditartrate in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- indocyanine green, lidocaine and vinorelbine ditartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 1997to 20 May 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed advanced solid tumor
- Any histology allowed
- Refractory to standard therapy OR no standard therapy exists
- Previously untreated non-small cell lung cancer allowed, provided abnormal liver function is present, defined as moderate (group 3) or severe (group 4)
- Measurable disease not required
- Present measurable disease requires baseline measurements within 4 weeks of study entry
- Patients with acute hepatitis from viral or drug etiologies should recover to a stable baseline prior to study therapy
- History of brain metastasis allowed, provided the following criteria are met:
- Metastasis has been controlled by radiotherapy or surgery
- Patient is not currently on corticosteroids
- Neurologic status is stable
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 2 months
- ANC = 1,500/mm³
- Platelet count = 100,000/mm³
- Hemoglobin = 10 g/dL (transfusion to this level allowed)
- Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/ min
- Patients with EKG evidence of first- or second-degree AV block or left or right bundle branch block are ineligible for the lidocaine bolus, but may otherwise be treated on this protocol
- Not pregnant or nursing
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Medical Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction
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.
Read the detailed description
OBJECTIVES:
- 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.
- Being tested
- indocyanine green, lidocaine, vinorelbine ditartrate, high performance liquid chromatography, intracellular fluorescence polarization analysis
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Determination of concentrations of vinorelbine and its metabolites
| Study group | Role | What they receive |
|---|---|---|
| Normal Liver Function | Experimental | Not described Receives: Drug: indocyanine green; Drug: lidocaine; Drug: vinorelbine ditartrate; Other: high performance liquid chromatography; Other: intracellular fluorescence polarization analysis; Other: liquid chromatography; Other: mass spectrometry; Other: pharmacological study |
| Mild Liver Dysfunction | Experimental | Not described Receives: Drug: indocyanine green; Drug: lidocaine; Drug: vinorelbine ditartrate; Other: high performance liquid chromatography; Other: intracellular fluorescence polarization analysis; Other: liquid chromatography; Other: mass spectrometry; Other: pharmacological study |
| Moderate Liver Dysfunction | Experimental | Not described Receives: Drug: indocyanine green; Drug: lidocaine; Drug: vinorelbine ditartrate; Other: high performance liquid chromatography; Other: intracellular fluorescence polarization analysis; Other: liquid chromatography; Other: mass spectrometry; Other: pharmacological study |
| Severe Liver Dysfunction | Experimental | Not described Receives: Drug: indocyanine green; Drug: lidocaine; Drug: vinorelbine ditartrate; Other: high performance liquid chromatography; Other: intracellular fluorescence polarization analysis; Other: liquid chromatography; Other: mass spectrometry; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve
Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.
Measured: 2 months post treatment
Number of Participants With Grade 3 and 4 Toxicities
Grade 3 \& 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.
Measured: 3 weeks after the stop of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study start20 Feb 1997
- Primary completion20 May 2010
- Study completion20 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Chao, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540982
- Sponsor's protocol ID
- 96032
- Other IDs
- P30CA033572, CHNMC-96032, CDR0000567457
- Status last verified
- Jun 2025
- First submitted
- 5 Oct 2007
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction
- ClinicalTrials.gov ID
- NCT00540982
- Acronym / sponsor ID
- 96032
- Keywords
- unspecified adult solid tumor, protocol specific, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 1997 (actual)
- Primary completion
- 20 May 2010 (actual)
- Study completion
- 20 May 2010 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Liver Function | Experimental | Drug: indocyanine green, Drug: lidocaine, Drug: vinorelbine ditartrate, Other: high performance liquid chromatography, Other: intracellular fluorescence polarization analysis, Other: liquid chromatography, Other: mass spectrometry, Other: pharmacological study |
| Mild Liver Dysfunction | Experimental | Drug: indocyanine green, Drug: lidocaine, Drug: vinorelbine ditartrate, Other: high performance liquid chromatography, Other: intracellular fluorescence polarization analysis, Other: liquid chromatography, Other: mass spectrometry, Other: pharmacological study |
| Moderate Liver Dysfunction | Experimental | Drug: indocyanine green, Drug: lidocaine, Drug: vinorelbine ditartrate, Other: high performance liquid chromatography, Other: intracellular fluorescence polarization analysis, Other: liquid chromatography, Other: mass spectrometry, Other: pharmacological study |
| Severe Liver Dysfunction | Experimental | Drug: indocyanine green, Drug: lidocaine, Drug: vinorelbine ditartrate, Other: high performance liquid chromatography, Other: intracellular fluorescence polarization analysis, Other: liquid chromatography, Other: mass spectrometry, Other: pharmacological study |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine green0.5 mg/kg will be administered by IV push to determine clearance | Drug | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| lidocaine1 mg/kg will be administered to determine metabolic capacity | Drug | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| vinorelbine ditartrateVarying doses ranging from 30 mg/m2 to 7.5 mg/m2 will be administered based upon liver function | Drug | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| high performance liquid chromatographyUsed to determine plasma concentrations of vinorelbine | Other | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| intracellular fluorescence polarization analysisUsed to determine concentration of lidocaine metabolic capacity | Other | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| liquid chromatographyUsed to determine concentrations of vinorelbine and its metabolites | Other | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| mass spectrometryUsed to determine concentrations of vinorelbine and its metabolites | Other | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
| pharmacological studyDetermination of concentrations of vinorelbine and its metabolites | Other | Mild Liver Dysfunction, Moderate Liver Dysfunction, Normal Liver Function, Severe Liver Dysfunction |
Primary outcome
Area Under the Curve
Time frame: 2 months post treatment
Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose.
Number of Participants With Grade 3 and 4 Toxicities
Time frame: 3 weeks after the stop of treatment
Grade 3 \& 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Chao study chair
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing indocyanine green, lidocaine and vinorelbine ditartrate in people with Lung Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (time frame: 2 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.