- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430144
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
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
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Seoul, Korea, Republic of
- National Cancer Center
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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
16 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 |
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Experimental: CKD-602
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Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
Other Names:
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Belotecan
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.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Belotecan(CKD-602)
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); ADC Therapeutics S.A.RecruitingRecurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Philadelphia Chromosome Positive | Blasts 5 Percent or More of Bone Marrow Nucleated Cells | CD22 PositiveUnited States
-
C.B. Fleet Company, Inc.CompletedBowel Cleansing Prior to ColonoscopyUnited States
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National Institute of Allergy and Infectious Diseases...Completed
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Med-El CorporationRecruitingHearing Loss, Conductive | Hearing Loss, MixedUnited States
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Chong Kun Dang PharmaceuticalCompletedHealthyKorea, Republic of
-
Chong Kun Dang PharmaceuticalCompletedHypertension | DyslipidemiasKorea, Republic of
-
National Institute of Allergy and Infectious Diseases...Completed
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Chong Kun Dang PharmaceuticalCompletedAlopeciaKorea, Republic of
-
Chong Kun Dang PharmaceuticalCompletedAlopeciaKorea, Republic of
-
Chong Kun Dang PharmaceuticalSeoul National University Bundang HospitalCompletedHealthyKorea, Republic of