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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Drug: Topotecan
* Drug: Belotecan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topotecan<br>Topotecan | Drug: Topotecan<br>* 1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression<br>* Other names: Hycamtin inj.;|
| Active Comparator: Camtobell<br>Belotecan | Drug: Belotecan<br>* 0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression<br>* Other names: Camtobell inj.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | approximately 21 days(every 1 Cycle) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | up to 4 years | 
| Progression Free survival |  | up tp 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelial Ovarian Cancer, Belotecan, Topotecan