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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sokbom Kang, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00430144
First received: January 31, 2007
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

-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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430144

Locations
Korea, Republic of
National cancer center
Seoul, Korea, Republic of
Sponsors and Collaborators
Sokbom Kang
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sokbom Kang, director, gynecologic oncology research branch, National Cancer Center, Korea
ClinicalTrials.gov 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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Belotecan
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014