Efficacy and Safety of Belotecan or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
Epithelial Ovarian Cancer
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
Epithelial Ovarian Cancer, Belotecan, Topotecan
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Topotecan Type: Drug
Name: Belotecan Type: Drug
Overall Status
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).
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Seoul National University Hospital
Seoul, Seoul Metropolitan, Korea, Republic of
Status: Recruiting
Contact: Yong-Sang Song, phD, Dr - 82-2-2072-2822 - yssong@snu.ac.kr
Start Date
January 2011
Completion Date
December 2014
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page