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
Trial Locations
- Locations (50)
NorthBay Healthcare System
πΊπΈFairfield, California, United States
University of Chicago Cancer Research Center
πΊπΈChicago, Illinois, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
St. Luke's Hospital
πΊπΈDuluth, Minnesota, United States
Medical Oncology, LLC
πΊπΈBaton Rouge, Louisiana, United States
Norris Cotton Cancer Center
πΊπΈLebanon, New Hampshire, United States
Sparrow Regional Cancer Center
πΊπΈLansing, Michigan, United States
McGill University
π¨π¦Montreal, Quebec, Canada
Veterans Affairs Medical Center - San Juan
π΅π·San Juan, Puerto Rico
Trinitas Hospital - Jersey Street Campus
πΊπΈElizabeth, New Jersey, United States
Arizona Clinical Research Center
πΊπΈTucson, Arizona, United States
Highlands Oncology Group, P.A.
πΊπΈFayetteville, Arkansas, United States
Berkshire Physicians and Surgeons, P.C.
πΊπΈPittsfield, Massachusetts, United States
Providence Hospital Cancer Center
πΊπΈSouthfield, Michigan, United States
Cancer Resource Center - Lincoln
πΊπΈLincoln, Nebraska, United States
Northern NJ Cancer Associates
πΊπΈHackensack, New Jersey, United States
Office of Luis Alberto Meza
πΊπΈLafayette, Louisiana, United States
Lakeland Medical Center - St. Joseph
πΊπΈSaint Joseph, Michigan, United States
Wilshire Oncology Medical Center
πΊπΈPomona, California, United States
South Bend Clinic and SurgiCenter
πΊπΈSouth Bend, Indiana, United States
Mercy Oncology-Hematology Limited
πΊπΈSaint Louis, Missouri, United States
Veterans Affairs Medical Center - Buffalo
πΊπΈBuffalo, New York, United States
Lakeridge Health Oshawa
π¨π¦Oshawa, Ontario, Canada
Office of Janak K. Choksi
πΊπΈBurlington, North Carolina, United States
Memphis Cancer Center
πΊπΈMemphis, Tennessee, United States
Cancer Centers of the Carolinas
πΊπΈGreenville, South Carolina, United States
Simmons Cancer Center - Dallas
πΊπΈDallas, Texas, United States
Hematology Oncology Consultants Inc
πΊπΈColumbus, Ohio, United States
Medical Group of Texas
πΊπΈDallas, Texas, United States
West Clinic, P.C.
πΊπΈMemphis, Tennessee, United States
Office of Hal Gerstein
πΊπΈGreat Neck, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
πΊπΈNew York, New York, United States
Raleigh Hematology/Oncology Associates - Wake Practice
πΊπΈRaleigh, North Carolina, United States
HillCrest Hospital
πΊπΈMayfield Heights, Ohio, United States
Veterans Affairs Medical Center - Tucson
πΊπΈTucson, Arizona, United States
Genesis Cancer Center
πΊπΈHot Springs, Arkansas, United States
Comprehensive Cancer Care Specialists of Boca Raton
πΊπΈBoca Raton, Florida, United States
West Florida Cancer Institute - Pensacola
πΊπΈPensacola, Florida, United States
Cancer Care Consultants of Northern California
πΊπΈRedding, California, United States
Saint Vincents Comprehensive Breast Center
πΊπΈNew York, New York, United States
Washington University Barnard Cancer Center
πΊπΈSaint Louis, Missouri, United States
Veterans Affairs Medical Center - Northport
πΊπΈNorthport, New York, United States
Joe Arrington Cancer Center
πΊπΈLubbock, Texas, United States
MultiCare Hematolgy/Oncology Clinic
πΊπΈTacoma, Washington, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
π΅π·San Juan, Puerto Rico
Barbara Ann Karmanos Cancer Institute
πΊπΈDetroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
πΊπΈWinston-Salem, North Carolina, United States
Lovelace Health Systems
πΊπΈAlbuquerque, New Mexico, United States
University of Rochester Cancer Center
πΊπΈRochester, New York, United States