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

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National cancer center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belotecan(CKD-602)

Drug

Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle

Other names: Camptobel

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sokbom Kang

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2010
First posted: Feb 1, 2007
Registry last updated: Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed