A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer

Inclusion Criteria

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