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