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Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

2014-07-24 14:35:26 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. It is not yet known whether giving vinorelbine by mouth or infusion is more effective in treating non- small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of vinorelbine given by mouth or as an infusion in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Description

OBJECTIVES: I. Compare the safety and efficacy of oral versus intravenous vinorelbine in patients with stage IIIB or IV non-small cell lung cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the pharmacokinetics of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral vinorelbine weekly. Arm II: Patients receive vinorelbine IV over 10 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed several times during treatment and 4 weeks after treatment. Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A maximum of 195 patients will be accrued for this study.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Lung Cancer

Intervention

vinorelbine ditartrate

Location

Arizona Clinical Research Center
Tucson
Arizona
United States
85712

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:35:26-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

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