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

Phase 2

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Drug: Topotecan; Drug: Belotecan

• Registration Number: NCT01630018
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topotecan	Topotecan	Topotecan
Camtobell	Belotecan	Belotecan

Primary Outcome Measures

Name	Time	Method
Objective response rate	approximately 21 days(every 1 Cycle)

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to 4 years
Progression Free survival	up tp 4 years

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Seoul Metropolitan, Korea, Republic of