title: Phase II trial of intraperitoneal carboplatin in ovarian carcinoma patients with macroscopic residual disease at second-look laparotomy. A multicentre study of the French Fédération Nationale des Centres de Lutte Contre le Cancer.
abstract: BACKGROUND
  Because of its antitumour activity and its pharmacological advantage when administered by the intraperitoneal route, carboplatin was studied in a phase II multicentric trial. The aim of the study was to determine the response rate and the toxicity of carboplatin administered intraperitoneally and to determine if pathological complete response could be attained in women with macroscopic residual ovarian cancer at second-look laparotomy after intravenous cisplatin chemotherapy.
  
  
  METHODS
  Twenty-nine patients with macroscopical residual disease after intravenous cisplatin-based chemotherapy at second-look laparotomy, were treated at that time with 300 mg/m2 of carboplatin administered in the abdominal cavity every four weeks for six cycles. In instances of negative findings at physical and CT scan examination, laparotomy evaluation was performed and the catheter was removed. The dose of carboplatin was increased or decreased according to hematological toxicity.
  
  
  RESULTS
  Efficacy is evaluable in 25 pts: 2 pts had pathological complete responses and 1 pt had microscopic disease (12% response rate of evaluable patients). Toxicity is evaluable for 135 cycles in 29 patients. No grade 4 hematological toxicity was observed, 2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia; grade 3 vomiting was observed in 11% of cycles. No peritoneal complication was observed; catheter dysfunction occurred after the first cycle in one patient who refused a surgical procedure to remove the catheter and to pursue treatment.
  
  
  CONCLUSIONS
  Intraperitoneal carboplatin demonstrates efficacy in patients with macroscopical residual disease at second-look laparotomy after first-line cisplatin chemotherapy. The recommended dose for further studies is 300 mg/m2 administered every 4 weeks. A low response rate does not favour a randomised study.
authors.affiliation: Centre Léon Bérard, Lyon, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Guastalla
authors.forename: C
authors.initials: C
authors.lastname: Lhomme
authors.forename: P
authors.initials: P
authors.lastname: Kerbrat
authors.forename: F
authors.initials: F
authors.lastname: Mayer
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: P
authors.initials: P
authors.lastname: Goupil
authors.forename: P
authors.initials: P
authors.lastname: Charrot
authors.forename: J F
authors.initials: JF
authors.lastname: Heron
authors.forename: M
authors.initials: M
authors.lastname: Chazard
authors.forename: I
authors.initials: I
authors.lastname: Richard
mesh_terms: D000328:Adult; D000368:Aged; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006801:Humans; D007274:Injections, Intraperitoneal; D007813:Laparotomy; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate
chemical_list: D016190:Carboplatin