Lung Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00005865

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 50 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00005865

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

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