PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically or cytologically confirmed small cell lung cancer (SCLC)
* If patient is treatment-naive, then they must have extensive disease
* If patients are not treatment-naive, then they must be classified as sensitive-relapse with either extensive disease or limited disease

  * Sensitive-relapse defined as disease that responded to first-line chemotherapy and relapsed more than 90 days following the last dose of first-line chemotherapy
  * Limited disease SCLC defined as disease confined to the hemithorax of origin, mediastinum, and/or ipsilateral supraclavicular lymph nodes, which could be encompassed within a tolerable radiotherapy port
  * Extensive disease defined as disease that does not fit the definition of limited disease as defined above
* Measurable or evaluable disease

Exclusion criteria:

* Active central nervous system (CNS) metastases, defined as metastases to the CNS (symptomatic or non-symptomatic) that requires immediate treatment or that are likely to require treatment in the following 6 weeks
* Medical conditions requiring urgent intervention, including any of the following:

  * Superior vena cava syndrome
  * Lobar obstruction
  * Spinal cord compression
  * Liver metastases involving greater than one-third of the liver

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN (if liver metastases are present) or ≤ 2 x ULN (if liver metastases are absent)
* Serum creatinine ≤ 1.5 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment

Exclusion criteria:

* Prior or concurrent malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or localized low-grade prostate cancer
* Hyponatremia (\< 130 mmol/L)
* Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:

  * Uncontrolled infection or infection requiring a concurrent parenteral antibiotic
  * Uncontrolled diabetes
  * Congestive heart failure
  * Myocardial infarction within the past 6 months
  * Chronic renal disease
  * Coagulopathy (excluding prophylactic anticoagulation)
* Known human immunodeficiency virus (HIV) positivity, hepatitis B surface antigen-positivity, or hepatitis C positivity with abnormal liver function tests

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics
* No concurrent prophylactic growth factors (filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during course 1 of study treatment

Exclusion criteria:

* More than one prior chemotherapy regimen for SCLC
* Less than 24 hours from any prior radiotherapy or the likelihood of toxicity from prior radiotherapy
* Radiotherapy to \> 25% of the bone marrow within the past 4 weeks
* Less than four weeks since major surgery