NCT00540982 is a Phase 1, PHASE2 clinical trial of indocyanine green in Lung Cancer, sponsored by City of Hope Medical Center.

Who is sponsoring NCT00540982?

NCT00540982 is sponsored by City of Hope Medical Center.

What drugs are being tested in NCT00540982?

Interventions in NCT00540982: indocyanine green, lidocaine, vinorelbine ditartrate, high performance liquid chromatography, intracellular fluorescence polarization analysis, liquid chromatography, mass spectrometry, pharmacological study.

What condition does NCT00540982 study?

NCT00540982 studies Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific.

Is NCT00540982 still recruiting?

NCT00540982 is currently completed. Last updated 2 July 2025.

Are results published for NCT00540982?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-02 · How we verify

NCT00540982

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 2 July 2025

What this trial tests

Phase 1, PHASE2 trial testing indocyanine green in Lung Cancer in 47 participants. Completed in 20 May 2010.

Timeline

20 February 1997

Primary endpoint
20 May 2010

20 May 2010

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	20 February 1997
Primary completion	20 May 2010
Estimated completion	20 May 2010
Sites	2 locations across United States

Drugs / interventions tested

indocyanine green (INDOCYANINE GREEN) — full drug profile →
lidocaine — full drug profile →
vinorelbine ditartrate — full drug profile →
high performance liquid chromatography
intracellular fluorescence polarization analysis
liquid chromatography
mass spectrometry — full drug profile →
pharmacological study — full drug profile →

Conditions studied

Lung Cancer — all drugs for Lung Cancer →
Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

City of Hope Medical Center

Who can join

Adults 18 to 120, any sex, with Lung Cancer or Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Curve Primary · 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.

Group	Value	95% CI
Normal	271	111 – 593
Mild	537	366 – 812
Moderate	341	251 – 1318
Severe	324	167 – 1090

Number of Participants With Grade 3 and 4 Toxicities Primary · 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.

Anemia

Group	Value	95% CI
Normal (30mg/m2)	1
Mild (30mg/m2)	0
Mild (20mg/m2)	2
Mild (15mg/m2)	0
Moderate (30mg/m2)	1
Moderate (15mg/m2)	3
Severe (20mg/m2)	1
Severe (7.5mg/m2)	0

Lymphopenia

Group	Value	95% CI
Normal (30mg/m2)	1
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	1
Severe (20mg/m2)	1
Severe (7.5mg/m2)	0

Neutropenia

Group	Value	95% CI
Normal (30mg/m2)	4
Mild (30mg/m2)	1
Mild (20mg/m2)	2
Mild (15mg/m2)	1
Moderate (30mg/m2)	7
Moderate (15mg/m2)	4
Severe (20mg/m2)	4
Severe (7.5mg/m2)	0

Thrombocytopenia

Group	Value	95% CI
Normal (30mg/m2)	0
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	1
Severe (20mg/m2)	2
Severe (7.5mg/m2)	0

Anorexia/weight loss

Group	Value	95% CI
Normal (30mg/m2)	0
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	1
Severe (20mg/m2)	1
Severe (7.5mg/m2)	0

Ascites

Group	Value	95% CI
Normal (30mg/m2)	0
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	0
Severe (20mg/m2)	1
Severe (7.5mg/m2)	0

Cerebrovascular ischemia

Group	Value	95% CI
Normal (30mg/m2)	0
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	1
Severe (20mg/m2)	0
Severe (7.5mg/m2)	0

Confusion

Group	Value	95% CI
Normal (30mg/m2)	0
Mild (30mg/m2)	0
Mild (20mg/m2)	0
Mild (15mg/m2)	0
Moderate (30mg/m2)	0
Moderate (15mg/m2)	0
Severe (20mg/m2)	1
Severe (7.5mg/m2)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded and graded throughout the study and until 30 days following the last dose of vinorelbine.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal (30mg/m2)

Serious: 0/11 (0%)

Deaths: 11/11

Mild (30mg/m2)

Serious: 0/1 (0%)

Deaths: 1/1

Mild (20mg/m2)

Serious: 0/3 (0%)

Deaths: 3/3

Mild (15mg/m2)

Serious: 0/2 (0%)

Deaths: 2/2

Moderate (30mg/m2)

Serious: 3/8 (38%)

Deaths: 8/8

Moderate (15mg/m2)

Serious: 0/10 (0%)

Deaths: 10/10

Severe (20mg/m2)

Serious: 4/7 (57%)

Deaths: 7/7

Severe (7.5mg/m2)

Serious: 0/5 (0%)

Deaths: 5/5

Serious adverse events (19 terms)

Reaction	System	Normal (30mg/m2)	Mild (30mg/m2)	Mild (20mg/m2)	Mild (15mg/m2)	Moderate (30mg/m2)	Moderate (15mg/m2)	Severe (20mg/m2)	Severe (7.5mg/m2)
General symptom	General disorders	—	—	—	—	—	—	—	—
Muscle weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Catheter related infection	Infections and infestations	—	—	—	—	—	—	—	—
Infection NOS	Infections and infestations	—	—	—	—	—	—	—	—
Infection, Bacterial (COH)	Infections and infestations	—	—	—	—	—	—	—	—
	Infections and infestations	—	—	—	—	—	—	—	—
Leukocyte count decreased	Investigations	—	—	—	—	—	—	—	—
Lymphopenia	Investigations	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Serum potassium decreased	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash desquamating	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—

Other adverse events (160 terms — click to expand)

Reaction	System	Normal (30mg/m2)	Mild (30mg/m2)	Mild (20mg/m2)	Mild (15mg/m2)	Moderate (30mg/m2)	Moderate (15mg/m2)	Severe (20mg/m2)	Severe (7.5mg/m2)
Fatigue	General disorders	—	—	—	—	—	—	—	—
Hemoglobin decreased	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Fluid Retention	General disorders	—	—	—	—	—	—	—	—
Hemorrhage	General disorders	—	—	—	—	—	—	—	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Stomatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Weight (Food Intake)	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Oedema NOS	General disorders	—	—	—	—	—	—	—	—
Allergy	Immune system disorders	—	—	—	—	—	—	—	—
AGC	Investigations	—	—	—	—	—	—	—	—
Bilirubin increased	Investigations	—	—	—	—	—	—	—	—
HGB/HCT	Investigations	—	—	—	—	—	—	—	—
Platelets	Investigations	—	—	—	—	—	—	—	—
WBC	Investigations	—	—	—	—	—	—	—	—
Blood glucose increased	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Serum albumin decreased	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Clinical (Physical Exam)	General disorders	—	—	—	—	—	—	—	—
Other Misc	General disorders	—	—	—	—	—	—	—	—
Fever (no infection)	General disorders	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—
Alkaline Phosphatase	Investigations	—	—	—	—	—	—	—	—
Bilirubin	Investigations	—	—	—	—	—	—	—	—
Leukocyte count decreased	Investigations	—	—	—	—	—	—	—	—
Leukopenia	Investigations	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—
SGOT/SGT	Investigations	—	—	—	—	—	—	—	—

Most-reported serious reactions: General symptom, Muscle weakness, Febrile neutropenia, Abdominal pain, Catheter related infection, Infection NOS, Infection, Bacterial (COH), .

Data from ClinicalTrials.gov NCT00540982 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Pilot Study of Vinorelbine Safety and Pharmacokinetics in Patients with Varying Degrees of Liver Dysfunction.
Gong J, Cho M, Gupta R, Synold TW, et al · · 2019 · cited 2× · PMID 30710067 · DOI 10.1634/theoncologist.2018-0336

Verify or expand the search:

Other trials of indocyanine green

Trials testing the same drug.

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Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

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Other City of Hope Medical Center trials

Trials by the same sponsor.

NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00540982 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 2 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00540982.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing