Efficacy and Safety of Belotecan or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
Conditions
Epithelial Ovarian Cancer
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
Epithelial Ovarian Cancer, Belotecan, Topotecan
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Topotecan Type: Drug
Name: Belotecan Type: Drug
Overall Status
Recruiting
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).
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
Location
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
Sponsors
Chong Kun Dang Pharmaceutical
Source
Chong Kun Dang Pharmaceutical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page