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