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

Sokbom Kang

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Belotecan(CKD-602)

Study type: Interventional

Funder types: Other

Identifiers

NCT00430144

NCCCTS-06-214

Details and patient eligibility

About

-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

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

CKD-602

Experimental group

Treatment:

Drug: Belotecan(CKD-602)