Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

Inclusion Criteria

• •Histological or cytological diagnosis of SCLC
• •Extensive disease (ED) at time of study entry
• •Response to first-line platinum-based chemotherapy
• •Recurrent or progressive SCLC ≥90 days after completion of first-line therapy
• •At least 18 years of age
• •ECOG Performance Status of 0, 1, or 2
• •Measurable disease defined by RECIST criteria
• •* Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.
• •* Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.
• •CT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the leions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (eg., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
• •Adequate organ function including the following:
• •* Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9 g/dL
• •* Hepatic: bilirubin ≤1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 X ULN
• •* Renal: serum creatinine \<2.0mg/dL or calculated creatinine clearance \>60mL/min
• •* Cardiac: Left ventricular ejection fraction (LVEF) ≥50%
• •Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods during the study.
• •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments