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

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer

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