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

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer Read More

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