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

Sokbom Kang16 enrolled

Overview

-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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

Belotecan(CKD-602)DRUG

Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National cancer center

Seoul, South Korea

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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