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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Belotecan; Camptothecin; Topotecan

Criteria

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