Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00005865
Last Updated: 2014-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2000-04-30
2007-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Alkaline phosphatase less than 5 times ULN (except in cases of bone or liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable or uncontrolled cardiac disease Pulmonary: No history of recurrent aspiration pneumonitis within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 9 days after study Able to swallow capsules intact No active infection within the past 2 weeks No unstable or uncontrolled medical conditions No other prior malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No history of peripheral neuropathy with severity greater than CALGB grade 1
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunologic therapy At least 1 week since prior hematopoietic growth factors or other blood products Chemotherapy: See Disease Characteristics No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery Other: At least 4 weeks since prior investigational device or drug No other concurrent anticancer therapy No other concurrent investigational device or drug
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Principal Investigators
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Tess Delacruz, RN, BSN
Role: STUDY_CHAIR
GlaxoSmithKline
Locations
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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
St Louis, Missouri, United States
Mercy Oncology-Hematology Limited
St 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
Countries
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References
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Hirsh V, Desjardins P, Needles BM, Rigas JR, Jahanzeb M, Nguyen L, Zembryki D, Leopold LH. Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC): A randomized phase II trial. Am J Clin Oncol. 2007 Jun;30(3):245-51. doi: 10.1097/01.coc.0000256103.21797.e5.
Other Identifiers
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GW-VINA2004
Identifier Type: -
Identifier Source: secondary_id
CDR0000067897
Identifier Type: -
Identifier Source: org_study_id
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