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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Tess Delacruz, RN, BSN
Study Chair
GlaxoSmithKline
United States: Federal Government
CDR0000067897
NCT00005865
April 2000
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
West Florida Cancer Institute - Pensacola | Pensacola, Florida 32514 |
Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
Medical Group of Texas | Dallas, Texas 75243 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Washington University Barnard Cancer Center | Saint Louis, Missouri 63110 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Providence Hospital Cancer Center | Southfield, Michigan 48075 |
Highlands Oncology Group, P.A. | Fayetteville, Arkansas 72703 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Wilshire Oncology Medical Center | Pomona, California 91767 |
St. Luke's Hospital | Duluth, Minnesota 55805-2193 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Berkshire Physicians and Surgeons, P.C. | Pittsfield, Massachusetts 01201 |
Joe Arrington Cancer Center | Lubbock, Texas 79410 |
West Clinic, P.C. | Memphis, Tennessee 38117 |
Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton, Florida 33428 |
Raleigh Hematology/Oncology Associates - Wake Practice | Raleigh, North Carolina 27609 |
Genesis Cancer Center | Hot Springs, Arkansas 71913 |
NorthBay Healthcare System | Fairfield, California 94533 |
Cancer Care Consultants of Northern California | Redding, California 96009-3100 |
South Bend Clinic and SurgiCenter | South Bend, Indiana 46634 |
Medical Oncology, LLC | Baton Rouge, Louisiana 70808 |
Office of Luis Alberto Meza | Lafayette, Louisiana 70503 |
Mercy Oncology-Hematology Limited | Saint Louis, Missouri 63141 |
Northern NJ Cancer Associates | Hackensack, New Jersey 07601 |
Lovelace Health Systems | Albuquerque, New Mexico 87108 |
Office of Hal Gerstein | Great Neck, New York 11022 |
Saint Vincents Comprehensive Breast Center | New York, New York 10011 |
Veterans Affairs Medical Center - Northport | Northport, New York 11768 |
Office of Janak K. Choksi | Burlington, North Carolina 27216 |
HillCrest Hospital | Mayfield Heights, Ohio 44124 |
Memphis Cancer Center | Memphis, Tennessee 38119 |
MultiCare Hematolgy/Oncology Clinic | Tacoma, Washington 98405 |