E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• •Stage IIIB or IV disease
• •Recurrent or progressive disease
• •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• •Must have received prior treatment with platinum-based therapy and a taxane
• •Asymptomatic brain metastasis allowed provided off steroids for \> 2 weeks
• •Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%
• •Life expectancy \> 3 months
• •Platelet count ≥ 100,000/mm³
• •Bilirubin ≤ 2.0 mg/dL
• •AST/ALT ≤ 2.5 times upper limit of normal
• •Creatinine normal OR creatinine clearance ≥ 50 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No neuropathy ≥ grade 2
• •No uncontrolled illness including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness or social situations that would preclude study compliance
• •No other concurrent investigational agents
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• •At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered
• •No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant setting
• •No concurrent combination antiretroviral therapy for HIV-positive patients