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