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

April 25, 2012 updated by: Sokbom Kang

A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

-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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Camptobel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sokbom Kang

Investigators

  • Principal Investigator: Sokbom Kang, National cancer cencer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-06-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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