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Vinorelbine in Treating Patients With Advanced Solid Tumors That Have Not Responded to Treatment and Liver Dysfunction
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: October 5, 2007   Last Updated: June 23, 2009   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00540982
  Purpose

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 phase I 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.


Condition Intervention Phase
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
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
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of indocyanine green and lidocaine metabolism with vinorelbine ditartrate pharmacokinetics [ Designated as safety issue: No ]
  • Pharmacokinetics of vinorelbine ditartrate as measured by high performance liquid chromatography (15) or by liquid chromatography/tandem mass spectrometry assay [ Designated as safety issue: No ]
  • Test of dose adjustment of vinorelbine ditartrate [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: December 1996
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540982

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
City of Hope Medical Group Recruiting
Pasadena, California, United States, 91105
Contact: Contact Person     Not Available        
Sponsors and Collaborators
Beckman Research Institute
Investigators
Study Chair: Stephen I. Shibata, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000567457, CHNMC-96032
Study First Received: October 5, 2007
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00540982     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Liver Diseases
Lidocaine
Vinblastine
Antimitotic Agents
Recurrence
Digestive System Diseases
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 28, 2009