Cervical Cancer
Conditions
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.
Interventions
DRUGBelotecan(CKD-602)
Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle
Sponsors
Sokbom Kang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed