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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630018
• Other study ID #: 11AOC09J
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2012
• Last updated: September 20, 2016
• Start date: January 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2016
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Topotecan
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
• Belotecan
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		approximately 21 days(every 1 Cycle)	No
Secondary	Overall Survival		up to 4 years	No
Secondary	Progression Free survival		up tp 4 years	No