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

Sokbom Kang1 site in 1 country16 target enrollmentJanuary 2007

ConditionsCervical Cancer

InterventionsBelotecan(CKD-602)

DrugsBelotecan(CKD-602)

Overview

Phase: Phase 2
Intervention: Belotecan(CKD-602)
Conditions: Cervical Cancer
Sponsor: Sokbom Kang
Enrollment: 16
Locations: 1
Primary Endpoint: overall response rate of belotecan (CKD-602)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

October 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Sokbom Kang

Responsible Party

Sponsor Investigator

Principal Investigator

Sokbom Kang

director, gynecologic oncology research branch

National Cancer Center, Korea

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