Clinical trial NCT01630018: Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial Ovarian Cancer
Belotecan
Topotecan
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: approximately 21 days(every 1 Cycle)
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 4 years
measure: Progression Free survival
timeFrame: up tp 4 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Metropolitan
Study officials:
affiliation: Seoul National University Hospital
name: Yong-Sang Song, phD, Dr
role: STUDY_CHAIR
References:
citation: Kim HS, Park SY, Park CY, Kim YT, Kim BJ, Song YJ, Kim BG, Kim YB, Cho CH, Kim JH, Song YS. A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer. Br J Cancer. 2021 Jan;124(2):375-382. doi: 10.1038/s41416-020-01098-8. Epub 2020 Sep 30.