Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy

Inclusion Criteria

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