title: Phase II study of belotecan (CKD 602) as a single agent in patients with recurrent or progressive carcinoma of uterine cervix.
abstract: OBJECTIVE
  The Phase II trial was conducted to evaluate the efficacy and toxicity of belotecan (CKD 602), a topoisomerase I inhibitor, in persistent or recurrent carcinoma of the cervix.
  
  
  METHODS
  Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle in patients with recurrent or progressive cervical carcinoma who were unsuitable candidates for curative treatment with surgery or radiotherapy.
  
  
  RESULTS
  At the first stage of trial, a total of 16 patients were entered in the study. A median of three cycles were administrated per patient with a range of one to seven cycles. Fourteen of 16 patients (87.5%) had received radiotherapy or chemotherapy prior to the study. The most frequently severe adverse events were anemia and neutropenia. More than Grade 3 anemia and neutropenia were seen in 10 cycles (23.8%) and 6 cycles (14.3%) of 42 cycles, respectively. The incidence of non-hematologic toxicity was minimal. One patient died of treatment-related toxicities. There was no complete or partial response to belotecan. The median overall survival was 12.38 months (95% confidence interval, 9.71-15.04).
  
  
  CONCLUSIONS
  Belotecan was not active in the treatment of recurrent or progressive cervical cancer as a single agent. ClinicalTrials.gov identifier: NCT00430144.
authors.affiliation: Center for Uterine Cancer, Research Institute and Hospital, National Cancer Center, 323 Illsan-ro, Ilsandong-gu, Goyang-Si, Gyeonggi-do 410-769, Republic of Korea.
authors.forename: Jong Ha
authors.initials: JH
authors.lastname: Hwang
authors.forename: Myong Cheol
authors.initials: MC
authors.lastname: Lim
authors.forename: Sang-Soo
authors.initials: SS
authors.lastname: Seo
authors.forename: Sang-Yoon
authors.initials: SY
authors.lastname: Park
authors.forename: Sokbom
authors.initials: S
authors.lastname: Kang
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001773:Blood Cells / Q000187:drug effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004064:Digestive System / Q000187:drug effects; D018450:Disease Progression; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009420:Nervous System / Q000187:drug effects; D012137:Respiratory System / Q000187:drug effects; D012867:Skin / Q000187:drug effects; D059004:Topoisomerase I Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology*
chemical_list: D000970:Antineoplastic Agents; D059004:Topoisomerase I Inhibitors; C116963:belotecan; D002166:Camptothecin