Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005865
Recruitment Status : Completed
First Posted : March 24, 2004
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: vinorelbine tartrate Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : April 2000
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005865

  Hide Study 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
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States, 72703
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
NorthBay Healthcare System
Fairfield, California, United States, 94533
Wilshire Oncology Medical Center
Pomona, California, United States, 91767
Cancer Care Consultants of Northern California
Redding, California, United States, 96009-3100
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
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Providence Hospital Cancer Center
Southfield, Michigan, United States, 48075
United States, Minnesota
St. Luke's Hospital
Duluth, Minnesota, United States, 55805
United States, Missouri
Washington University Barnard Cancer Center
Saint Louis, Missouri, United States, 63110
Mercy Oncology-Hematology Limited
Saint Louis, Missouri, United States, 63141
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
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, United States, 07201
Northern NJ Cancer Associates
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Lovelace Health Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Office of Hal Gerstein
Great Neck, New York, United States, 11022
Saint Vincents Comprehensive Breast Center
New York, New York, United States, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Veterans Affairs Medical Center - Northport
Northport, New York, United States, 11768
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Office of Janak K. Choksi
Burlington, North Carolina, United States, 27216
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States, 27609
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Hematology Oncology Consultants Inc
Columbus, Ohio, United States, 43235
HillCrest Hospital
Mayfield Heights, Ohio, United States, 44124
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
West Clinic, P.C.
Memphis, Tennessee, United States, 38117
Memphis Cancer Center
Memphis, Tennessee, United States, 38119
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Medical Group of Texas
Dallas, Texas, United States, 75243
Joe Arrington Cancer Center
Lubbock, Texas, United States, 79410
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
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Study Chair: Tess Delacruz, RN, BSN GlaxoSmithKline

Publications of Results: Identifier: NCT00005865     History of Changes
Other Study ID Numbers: CDR0000067897
First Posted: March 24, 2004    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: June 2007

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents