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

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

• 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.

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