PR104 in Treating Patients With Previously Untreated or Relapsed Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: PR104; F-18-fluoromisonidazole
Intervention description: administered at a dose of 1100 mg/m^2 by intravenous infusion over 1 hour and repeated every three weeks; administered intravenously prior to PET scan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with
      previously untreated or relapsed small cell lung cancer (SCLC).
    

Eligibility 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