BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed non-small cell lung cancer
• Measurable disease
• * A CNS lesion cannot be the sole target lesion
• Must be taxane-resistant as defined by the following criteria:
• * At least 1 prior course (3 weeks of continuous therapy) of a taxane
• * Progressive disease developed either during or within 6 months after therapy
• No metastatic brain or meningeal tumors unless the following criteria apply:
• * More than 6 months since definitive therapy
• * Negative imaging study within the past 4 weeks
• * Clinically stable with respect to the tumor
• * No concurrent acute steroid therapy or taper
• * Chronic steroids allowed provided dose is stable for 1 month before and after screening radiography
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9.0 g/dL
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT and AST no greater than 2.5 times ULN (5 times ULN if liver involvement)
• No chronic hepatitis B or C
• Renal
• Creatinine no greater than 1.5 times ULN
• Cardiovascular
• No congestive heart failure
• No serious cardiac arrhythmias
• No active coronary disease or ischemia
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• HIV negative
• No active clinically serious infection
• No history of seizure disorder
• * History of seizures related to brain metastasis allowed if seizure free for the past 2 months
• No prior hypersensitivity to taxane compounds that was unmanageable with premedication
• No pre-existing peripheral neuropathy greater than grade 1
• No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, and T1)
• No substance abuse
• No medical, psychological, or social condition that would preclude study participation or evaluation
• No condition that is unstable or would jeopardize patient safety and study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• More than 3 weeks since prior anticancer immunotherapy
• More than 3 weeks since prior biologic response modifiers (e.g., filgrastim \[G-CSF\])
• More than 4 months since prior bone marrow transplantation or stem cell rescue
• No concurrent anticancer immunotherapy
• Concurrent epoetin alfa allowed if dose is stable for the past 2 months
• Chemotherapy
• See Disease Characteristics
• More than 3 weeks since prior anticancer chemotherapy (6 weeks for mitomycin or nitrosoureas)
• No more than 2 prior anticancer chemotherapy regimens (adjuvant therapy is not included unless cancer recurred during or within 6 months after completion of adjuvant therapy)
• No prior oxaliplatin
• No other concurrent chemotherapy
• Endocrine therapy
• See Disease Characteristics
• Radiotherapy
• More than 3 weeks since prior radiotherapy
• No concurrent non-palliative radiotherapy
• * Palliative radiotherapy allowed provided that all of the following criteria are met:
• * No progressive disease
• * No more than 10% of the bone marrow is irradiated
• * Radiation field does not encompass a target lesion
• Surgery
• More than 4 weeks since prior surgery
• No prior organ allograft
• Other
• More than 4 weeks since prior investigational drug therapy
• No concurrent non-conventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements that would interfere with study endpoints
• No other concurrent investigational drug therapy
• No other concurrent anticancer therapy