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Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Belotecan(CKD-602)
Sponsored by
Sokbom Kang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
  • One of the following histologic types
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Adenosquamous carcinoma
  • Clinically measurable disease
  • Performance status of 0, 1, 2 on the ECOG criteria

Exclusion Criteria:

  • Histology of neuroendocrine tumors
  • Patient previously treated with topoisomerase-I inhibitor

Sites / Locations

  • National cancer center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CKD-602

Arm Description

Outcomes

Primary Outcome Measures

overall response rate of belotecan (CKD-602)

Secondary Outcome Measures

Full Information

First Posted
January 31, 2007
Last Updated
April 25, 2012
Sponsor
Sokbom Kang
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1. Study Identification

Unique Protocol Identification Number
NCT00430144
Brief Title
Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
Official Title
A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sokbom Kang

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
-list item one, The purpose of this study is to evaluate the overall response rate of belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix
Detailed Description
list item one, to evaluate toxicities of Belotecan list item two, to evaluate duration of primary response for responding patients list item three, to evaluate time to disease progression list item four, to evaluate progression free survival and overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD-602
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Belotecan(CKD-602)
Other Intervention Name(s)
Camptobel
Intervention Description
Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
Primary Outcome Measure Information:
Title
overall response rate of belotecan (CKD-602)
Time Frame
1 week before the start of Cycle 4, 3 weeks later Cycle 6 or at discontinuation of study treatment, and then at least every 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy. One of the following histologic types Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Clinically measurable disease Performance status of 0, 1, 2 on the ECOG criteria Exclusion Criteria: Histology of neuroendocrine tumors Patient previously treated with topoisomerase-I inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sokbom Kang
Organizational Affiliation
National cancer cencer
Official's Role
Principal Investigator
Facility Information:
Facility Name
National cancer center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21355002
Citation
Hwang JH, Lim MC, Seo SS, Park SY, Kang S. Phase II study of belotecan (CKD 602) as a single agent in patients with recurrent or progressive carcinoma of uterine cervix. Jpn J Clin Oncol. 2011 May;41(5):624-9. doi: 10.1093/jjco/hyr017. Epub 2011 Feb 24.
Results Reference
derived

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Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

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