Efficacy and Safety of Belotecan or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer (AOC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01630018
First received: March 6, 2012
Last updated: September 3, 2013
Last verified: September 2013

March 6, 2012
September 3, 2013
January 2011
May 2014   (final data collection date for primary outcome measure)
Objective response rate [ Time Frame: approximately 21 days(every 1 Cycle) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01630018 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Progression Free survival [ Time Frame: up tp 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Belotecan or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer
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

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).

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epithelial Ovarian Cancer
  • 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.
  • 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.
  • Active Comparator: Topotecan
    Topotecan
    Intervention: Drug: Topotecan
  • Active Comparator: Camtobell
    Belotecan
    Intervention: Drug: Belotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2014
May 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Yong-Sang Song, phD, Dr 82-2-2073-2822 yssong@snu.ac.kr
Korea, Republic of
 
NCT01630018
11AOC09J
Yes
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Not Provided
Study Chair: Yong-Sang Song, phD, Dr Seoul National University Hospital
Chong Kun Dang Pharmaceutical
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP