Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix
Phase 2
Completed
- Conditions
- Cervical Cancer
- Interventions
- Drug: Belotecan(CKD-602)
- Registration Number
- NCT00430144
- Lead Sponsor
- Sokbom Kang
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CKD-602 Belotecan(CKD-602) -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National cancer center
🇰🇷Seoul, Korea, Republic of