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

This study has been completed.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical Identifier:
First received: March 6, 2012
Last updated: September 20, 2016
Last verified: September 2016
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 Intervention Phase
Epithelial Ovarian Cancer
Drug: Topotecan
Drug: Belotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: approximately 21 days(every 1 Cycle) ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: up to 4 years ]
  • Progression Free survival [ Time Frame: up tp 4 years ]

Enrollment: 141
Study Start Date: January 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topotecan
Drug: Topotecan
1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Other Name: Hycamtin inj.
Active Comparator: Camtobell
Drug: Belotecan
0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
Other Name: Camtobell inj.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01630018

Korea, Republic of
Seoul National University Hospital
Seoul, Seoul Metropolitan, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Study Chair: Yong-Sang Song, phD, Dr Seoul National University Hospital
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01630018     History of Changes
Other Study ID Numbers: 11AOC09J
Study First Received: March 6, 2012
Last Updated: September 20, 2016

Keywords provided by Chong Kun Dang Pharmaceutical:
Epithelial Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic processed this record on May 22, 2017