title: Phase II study of carboplatin and weekly irinotecan combination chemotherapy in recurrent ovarian cancer: a Kansai clinical oncology group study (KCOG0330).
abstract: BACKGROUND
  A multicenter phase II trial was conducted to evaluate the efficacy and toxicity of irinotecan plus carboplatin chemotherapy in patients with epithelial ovarian cancer (EOC).
  
  
  METHODS
  Patients with either radiologically- or serologically-recurrent EOC were administered intravenous irinotecan (60 mg/m(2); days 1 and 8) and carboplatin area under the curve of 5 mg/ml/min (day 1), repeated every 21 days. The primary end-point was response rate (RR), while the secondary end-points were adverse events and progression-free survival (PFS).
  
  
  RESULTS
  Between 2005 and 2009, 40 patients (median age=59 years) with EOC were enrolled. Intention-to-treat analysis showed an RR of 43% [95% confidence interval (CI)=27-58%]. For patients with a platinum-free interval (PFI) of <6 months, overall RR based on RECIST was 21% (95% CI=0-43%) and median PFS was 3.7 months (95% CI=2.5-7.7 months), while those in patients with PFI ≥6 months were 52% (95% CI=31-74%) and 9.1 months (95% CI=7.9-11.2 months), respectively. Grade 3/4 toxicity encountered during the first cycle included G3/G4 neutropenia in 65% of patients (12/14), G3/G4 thrombocytopenia in 48% (18/1), G3 febrile neutropenia in 5% (2), G3 nausea in 5% (2), G3 diarrhea in 5% (2), and G3 fatigue in 5% of patients (2).
  
  
  CONCLUSIONS
  This carboplatin plus irinotecan combination demonstrated a modest activity in recurrent EOC. However, considering its hematological toxicities, the regimen should be further investigated to establish the feasibility of the modified dose for platinum-sensitive disease.
authors.affiliation: Department of Obstetrics and Gynecology, Hyogo College of Medicine, Mukogawa 1-1, Nishinomiya, Hyogo 663-8501, Japan. tsuba@hyo-med.ac.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tsubamoto
authors.forename: Ryuji
authors.initials: R
authors.lastname: Kawaguchi
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Ito
authors.forename: Takaya
authors.initials: T
authors.lastname: Shiozaki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Takeuchi
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Itani
authors.forename: Atsushi
authors.initials: A
authors.lastname: Arakawa
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tabata
authors.forename: Shinji
authors.initials: S
authors.lastname: Toyoda
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000097:blood; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077216:Carcinoma, Ovarian Epithelial; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality
chemical_list: D018394:CA-125 Antigen; D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin