Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

Inclusion Criteria: * At least 18 years of age * Histological or cytological diagnosis of AOC * Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy * Measurable disease defined by RECIST criteria * ECOG Performance Status of 0, 1, or 2 * Life expectancy \> 3 months * Adequate bone marrow, Renal, Hepatic reserve: * absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL * platelet count ≥ 100,000 cells/μL * hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 X ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN * Alkaline Phosphatase (ALP) ≤ 2.0 X ULN * Serum creatinine \< 1.5mg/dL or calculated creatinine clearance \> 60mL/min * Signed a written informed consent Exclusion Criteria: * Active infection * Symptomatic brain lesion * Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases * Prior anticancer therapy within 4 weeks before enroll * Active pregnancy test and Pregnant or nursing women * Participation in any investigational drug study within 28 days prior to study entry