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

OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or
IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to
progression in patients treated with this drug. III. Determine the toxicity of this drug in
these patients. IV. Determine whether there is a perceived preference for this oral
administration in these patients. V. Determine the quality of life of these patients when
treated with this drug. VI. Assess individual variation in responses, pharmacokinetic
parameters, and/or biological correlates in patients treated with this drug.

OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every
28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed
every 3 months for 5 years.

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIB or IV non-small cell lung
cancer Measurable disease At least 1 lesion that is 2.0 cm or more in longest diameter CNS
metastases allowed if previously treated and clinically stable for at least 8 weeks prior
to study No meningeal carcinomatosis Participation in translational research component of
this study is mandatory

PATIENT CHARACTERISTICS: Age: 65 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10.0
g/dL Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 2.0
mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: No dysphagia
or inability to swallow capsules intact No peripheral neuropathy grade 2 or greater No
other significant medical condition that would preclude study No active infection within
the past 2 weeks No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this disease within the past 5 years Endocrine therapy: Not specified
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior
radiotherapy to more than 25% of bone marrow No prior radiotherapy to measurable lesion
unless documented progression after therapy No concurrent radiotherapy, including
palliative radiotherapy Surgery: At least 3 weeks since prior major surgery