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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00540982 |
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 |
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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 |
Estimated Enrollment: | 25 |
Study Start Date: | December 1996 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced solid tumor
Refractory to standard therapy OR no standard therapy exists
Measurable disease not required
History of brain metastasis allowed, provided the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Stephen I. Shibata, MD | Beckman Research Institute |
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 |
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 |
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 |
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 |