Spots Global Cancer Trial Database for Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title: A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer
Study ID: NCT00005865
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
South Bend Clinic and SurgiCenter, South Bend, Indiana, United States
Medical Oncology, LLC, Baton Rouge, Louisiana, United States
Office of Luis Alberto Meza, Lafayette, Louisiana, United States
Berkshire Physicians and Surgeons, P.C., Pittsfield, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States
Providence Hospital Cancer Center, Southfield, Michigan, United States
St. Luke's Hospital, Duluth, Minnesota, United States
Washington University Barnard Cancer Center, Saint Louis, Missouri, United States
Mercy Oncology-Hematology Limited, Saint Louis, Missouri, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Trinitas Hospital - Jersey Street Campus, Elizabeth, New Jersey, United States
Northern NJ Cancer Associates, Hackensack, New Jersey, United States
Lovelace Health Systems, Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Office of Hal Gerstein, Great Neck, New York, United States
Saint Vincents Comprehensive Breast Center, New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Veterans Affairs Medical Center - Northport, Northport, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
Office of Janak K. Choksi, Burlington, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Hematology Oncology Consultants Inc, Columbus, Ohio, United States
HillCrest Hospital, Mayfield Heights, Ohio, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
West Clinic, P.C., Memphis, Tennessee, United States
Memphis Cancer Center, Memphis, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
Medical Group of Texas, Dallas, Texas, United States
Joe Arrington Cancer Center, Lubbock, Texas, United States
MultiCare Hematolgy/Oncology Clinic, Tacoma, Washington, United States
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan, , Puerto Rico
Contact Details
Name: Tess Delacruz, RN, BSN
Affiliation: GlaxoSmithKline
Role: STUDY_CHAIR
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