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.
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.
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
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There are 50 Locations for this study
Tucson Arizona, 85712, United States
Tucson Arizona, 85723, United States
Fayetteville Arkansas, 72703, United States
Hot Springs Arkansas, 71913, United States
Fairfield California, 94533, United States
Pomona California, 91767, United States
Redding California, 96009, United States
Boca Raton Florida, 33428, United States
Pensacola Florida, 32514, United States
Chicago Illinois, 60637, United States
South Bend Indiana, 46634, United States
Baton Rouge Louisiana, 70808, United States
Lafayette Louisiana, 70503, United States
Pittsfield Massachusetts, 01201, United States
Detroit Michigan, 48201, United States
Lansing Michigan, 48909, United States
Saint Joseph Michigan, 49085, United States
Southfield Michigan, 48075, United States
Duluth Minnesota, 55805, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Lincoln Nebraska, 68510, United States
Lebanon New Hampshire, 03756, United States
Elizabeth New Jersey, 07201, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87108, United States
Buffalo New York, 14215, United States
Great Neck New York, 11022, United States
New York New York, 10011, United States
New York New York, 10016, United States
Northport New York, 11768, United States
Rochester New York, 14642, United States
Burlington North Carolina, 27216, United States
Raleigh North Carolina, 27609, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43235, United States
Mayfield Heights Ohio, 44124, United States
Pittsburgh Pennsylvania, 15213, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38117, United States
Memphis Tennessee, 38119, United States
Dallas Texas, 75235, United States
Dallas Texas, 75243, United States
Lubbock Texas, 79410, United States
Tacoma Washington, 98405, United States
Oshawa Ontario, L1G 2, Canada
Montreal Quebec, H2W 1, Canada
San Juan , 00927, Puerto Rico
San Juan , 00936, Puerto Rico
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