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