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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01630018

Enrollment

141

Registered

2012-06-28

Start date

2011-01-31

Completion date

2014-06-30

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial Ovarian Cancer, Belotecan, Topotecan

Brief 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

Interventions

DRUGTopotecan

1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression

DRUGBelotecan

0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	approximately 21 days(every 1 Cycle)

Secondary

Measure	Time frame
Overall Survival	up to 4 years
Progression Free survival	up tp 4 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026