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

NCT ID: NCT00430144

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-10-31

Brief Summary

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-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

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* 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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CKD-602

Group Type EXPERIMENTAL

Belotecan(CKD-602)

Intervention Type DRUG

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

Interventions

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Belotecan(CKD-602)

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

Intervention Type DRUG

Other Intervention Names

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Camptobel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sokbom Kang

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sokbom Kang

director, gynecologic oncology research branch

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sokbom Kang

Role: PRINCIPAL_INVESTIGATOR

National cancer cencer

Locations

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National cancer center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hwang JH, Lim MC, Seo SS, Park SY, Kang S. Phase II study of belotecan (CKD 602) as a single agent in patients with recurrent or progressive carcinoma of uterine cervix. Jpn J Clin Oncol. 2011 May;41(5):624-9. doi: 10.1093/jjco/hyr017. Epub 2011 Feb 24.

Reference Type DERIVED
PMID: 21355002 (View on PubMed)

Other Identifiers

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NCCCTS-06-214

Identifier Type: -

Identifier Source: org_study_id

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