Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed advanced solid tumor

- Any histology allowed

- Refractory to standard therapy OR no standard therapy exists

- Previously untreated non-small cell lung cancer allowed, provided abnormal liver
function is present, defined as moderate (group 3) or severe (group 4)

- Measurable disease not required

- Present measurable disease requires baseline measurements within 4 weeks of
study entry

- Patients with acute hepatitis from viral or drug etiologies should recover to a
stable baseline prior to study therapy

- History of brain metastasis allowed, provided the following criteria are met:

- Metastasis has been controlled by radiotherapy or surgery

- Patient is not currently on corticosteroids

- Neurologic status is stable

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Life expectancy ≥ 2 months

- ANC = 1,500/mm³

- Platelet count = 100,000/mm³

- Hemoglobin = 10 g/dL (transfusion to this level allowed)

- Creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/ min

- Patients with EKG evidence of first- or second-degree AV block or left or right
bundle branch block are ineligible for the lidocaine bolus, but may otherwise be
treated on this protocol

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent illness (e.g., cardiovascular, pulmonary, or central nervous system)
that is poorly controlled or of such severity that the investigator deems unwise to
enter the patient on protocol

- Must have ability to comply with study treatment and required tests

- Obstructive jaundice requires a drainage procedure prior to study treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea
therapy)

- No prior radiotherapy to > 30% of the bone marrow or more than standard adjuvant
pelvic radiotherapy for rectal cancer