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

This study has been completed.
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea Identifier:
First received: January 31, 2007
Last updated: April 25, 2012
Last verified: April 2012

-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

Condition Intervention Phase
Cervical Cancer
Drug: Belotecan(CKD-602)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

Resource links provided by NLM:

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: October 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-602 Drug: Belotecan(CKD-602)
Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
Other Name: Camptobel

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00430144

Korea, Republic of
National cancer center
Seoul, Korea, Republic of
Sponsors and Collaborators
Sokbom Kang
Principal Investigator: Sokbom Kang National cancer cencer
  More Information

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sokbom Kang, director, gynecologic oncology research branch, National Cancer Center, Korea Identifier: NCT00430144     History of Changes
Other Study ID Numbers: NCCCTS-06-214
Study First Received: January 31, 2007
Last Updated: April 25, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses processed this record on April 17, 2014