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A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

Phase 2
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

A Phase II Study 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate of belotecan (CKD-602)

Outcome 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

Safety Issue:


Principal Investigator

Sokbom Kang

Investigator Role:

Principal Investigator

Investigator Affiliation:

National cancer cencer


Korea: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

October 2010

Related Keywords:

  • Cervical Cancer
  • Carcinoma
  • Uterine Cervical Neoplasms