VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.

OBJECTIVES:

* Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M.
* Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse \[progressive disease \> 3 months after responding to first-line chemotherapy\] vs resistant disease \[progressive disease during or ≤ 3 months after first-line chemotherapy\]).

Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR.

After completion of study treatment, patients are followed periodically for up to 18 months.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically confirmed small cell lung cancer

  * Locally advanced or metastatic disease
  * Recurrent or progressive disease after first-line standard cytotoxic therapy
* Measurable or evaluable disease
* Brain metastasis allowed

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 2 months
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.5 mg/dL
* AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active uncontrolled bleeding
* No active infection
* Must not require supplemental oxygen at rest
* No active heart disease
* No myocardial infarction within the past 3 months
* No uncontrolled congestive heart failure
* No uncontrolled arrhythmias
* No uncontrolled coronary artery disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)

  * Prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones)
* At least 2 weeks since prior surgery or hormonal therapy
* Must not require any immediate palliative treatment including surgery
* Must have recovered from prior anticancer therapy

  * Persistent, stable chronic toxic effects ≤ grade 1 are allowed
* No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
* No other concurrent anticancer therapy
* No other concurrent investigational agent
* No concurrent disulfiram