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