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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430144
• Other study ID #: NCCCTS-06-214
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2007
• Last updated: April 25, 2012
• Start date: January 2007
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Belotecan(CKD-602)
Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle

Locations

Country	Name	City	State
Korea, Republic of	National cancer center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sokbom Kang

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate of belotecan (CKD-602)		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	Yes