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

Inclusion 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