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