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Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005865
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: vinorelbine ditartrate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer not amenable to combination chemotherapy, curative surgery, or radiotherapy Bidimensionally measurable disease

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005865

  Hide Study Locations
Locations
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States, 72703
United States, California
Cancer Care Consultants of Northern California
Redding, California, United States, 96009-3100
NorthBay Healthcare System
Fairfield, California, United States, 94533
Wilshire Oncology Medical Center
Pomona, California, United States, 91767
United States, Florida
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States, 33428
West Florida Cancer Institute - Pensacola
Pensacola, Florida, United States, 32514
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
South Bend Clinic and SurgiCenter
South Bend, Indiana, United States, 46634
United States, Louisiana
Medical Oncology, LLC
Baton Rouge, Louisiana, United States, 70808
Office of Luis Alberto Meza
Lafayette, Louisiana, United States, 70503
United States, Massachusetts
Berkshire Physicians and Surgeons, P.C.
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Providence Hospital Cancer Center
Southfield, Michigan, United States, 48075
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
United States, Minnesota
St. Luke's Hospital
Duluth, Minnesota, United States, 55805
United States, Missouri
Mercy Oncology-Hematology Limited
Saint Louis, Missouri, United States, 63141
Washington University Barnard Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510-4844
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Northern NJ Cancer Associates
Hackensack, New Jersey, United States, 07601
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
United States, New Mexico
Lovelace Health Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Office of Hal Gerstein
Great Neck, New York, United States, 11022
Saint Vincents Comprehensive Breast Center
New York, New York, United States, 10011
Veterans Affairs Medical Center - Northport
Northport, New York, United States, 11768
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Office of Janak K. Choksi
Burlington, North Carolina, United States, 27216
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States, 27609
United States, Ohio
Hematology Oncology Consultants Inc
Columbus, Ohio, United States, 43235
HillCrest Hospital
Mayfield Heights, Ohio, United States, 44124
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
Memphis Cancer Center
Memphis, Tennessee, United States, 38119
West Clinic, P.C.
Memphis, Tennessee, United States, 38117
United States, Texas
Joe Arrington Cancer Center
Lubbock, Texas, United States, 79410
Medical Group of Texas
Dallas, Texas, United States, 75243
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Washington
MultiCare Hematolgy/Oncology Clinic
Tacoma, Washington, United States, 98405
Canada, Ontario
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: Tess Delacruz, RN, BSN GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067897, GW-VINA2004
Study First Received: June 2, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005865     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009