Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00005865
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (50)
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Highlands Oncology Group, P.A.
🇺🇸Fayetteville, Arkansas, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
NorthBay Healthcare System
🇺🇸Fairfield, California, United States
Wilshire Oncology Medical Center
🇺🇸Pomona, California, United States
Cancer Care Consultants of Northern California
🇺🇸Redding, California, United States
Comprehensive Cancer Care Specialists of Boca Raton
🇺🇸Boca Raton, Florida, United States
West Florida Cancer Institute - Pensacola
🇺🇸Pensacola, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Scroll for more (40 remaining)Arizona Clinical Research Center🇺🇸Tucson, Arizona, United States