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

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT01630018

Collaborator

(none)

141

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer	Drug: Topotecan Drug: Belotecan	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

141 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Topotecan Topotecan	Drug: Topotecan 1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression Other Names: Hycamtin inj.
Active Comparator: Camtobell Belotecan	Drug: Belotecan 0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression Other Names: Camtobell inj.

Arm

Intervention/Treatment

Active Comparator: Topotecan

Topotecan

Drug: Topotecan

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

Other Names:

Hycamtin inj.

Active Comparator: Camtobell

Belotecan

Drug: Belotecan

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

Other Names:

Camtobell inj.

Outcome Measures

Primary Outcome Measures

Objective response rate [approximately 21 days(every 1 Cycle)]

Secondary Outcome Measures

Overall Survival [up to 4 years]
Progression Free survival [up tp 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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