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

Exclusion Criteria

• Absolute neutrophil count ≥ 1,500/mm³
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to E7389