title: Phase II study of belotecan, a camptothecin analogue, in combination with carboplatin for the treatment of recurrent ovarian cancer.
abstract: BACKGROUND
  Belotecan (CKD602; Camtobell, Chong Keun Dang Corp., Seoul, Korea) is a recently developed camptothecin derivative with antitumor properties. This phase II study was designed to evaluate the toxicity and efficacy of belotecan combined with carboplatin in patients with recurrent epithelial ovarian cancer (EOC).
  
  
  METHODS
  Thirty-eight patients with recurrent EOC were treated with belotecan 0.3 mg/m(2) /day (days 1-5) and carboplatin AUC 5 (day 5) every 3 weeks for 6 cycles. The primary objective was to determine the response rate as defined by Response Evaluation Criteria in Solid Tumors and CA-125 response. Other end points included toxicities and progression-free survival (PFS).
  
  
  RESULTS
  All 38 patients were assessed for toxicity, and 35 patients were assessed for response. The overall response rate was 57.1%; there were 7 complete responses (20.0%), 13 partial responses (37.1%), 6 patients with stable disease (17.1%), and 9 patients with progressive disease (25.7%). Grades 3 and 4 hematologic toxicities included neutropenia (28.8%), thrombocytopenia (19.8%), and anemia (14.4%), and there were 2 episodes of febrile neutropenia. Median PFS was 7 months, with a median follow-up of 12 months.
  
  
  CONCLUSIONS
  The newly developed topoisomerase I inhibitor belotecan (CKD-602) combined with carboplatin is a well-tolerated regimen with activity in recurrent EOC. Further testing of this regimen is warranted to further characterize efficacy and indications for use.
authors.affiliation: Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Chel Hun
authors.initials: CH
authors.lastname: Choi
authors.forename: Yoo-Young
authors.initials: YY
authors.lastname: Lee
authors.forename: Tae-Jong
authors.initials: TJ
authors.lastname: Song
authors.forename: Hwang-Shin
authors.initials: HS
authors.lastname: Park
authors.forename: Min Kyu
authors.initials: MK
authors.lastname: Kim
authors.forename: Tae-Joong
authors.initials: TJ
authors.lastname: Kim
authors.forename: Jeong-Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Je-Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Duk-Soo
authors.initials: DS
authors.lastname: Bae
authors.forename: Byoung-Gie
authors.initials: BG
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy*
chemical_list: C116963:belotecan; D016190:Carboplatin; D002166:Camptothecin