title: Intraperitoneal treatment with the trifunctional bispecific antibody Catumaxomab in patients with platinum-resistant epithelial ovarian cancer: a phase IIa study of the AGO Study Group.
abstract: OBJECTIVE
  The aim of this study was to select the best catumaxomab regimen for further investigation in ovarian cancer based on confirmed tumour response.
  
  
  METHODS
  Randomised open-label phase IIa study in women with platinum-resistant or -refractory epithelial ovarian cancer. Catumaxomab (6-hour intraperitoneal infusion on days 0, 3, 7 and 10) was administered at a low (10, 10, 10 and 10 μg) or high dose (10, 20, 50 and 100 μg). Responders were patients with either a complete (CR) or partial (PR) response.
  
  
  RESULTS
  Forty-five patients were randomised to receive either low dose (23) or high dose (22). There were no responders in the low-dose versus one patient (5%) in the high-dose group with a PR. In the low-dose group, two patients (9%) had stable disease compared with five patients (23%) in the high-dose group. Catumaxomab was well tolerated and there was no difference between the dose groups in the incidence of treatment-induced adverse events, the most common of which were gastrointestinal and injection-site reactions.
  
  
  CONCLUSIONS
  Catumaxomab had modest activity in platinum-resistant ovarian cancer. The high-dose regimen was associated with a slightly better therapeutic index than the low dose regimen.
authors: University of Marburg, Department of Gynaecology, Marburg, Germany. baumannk@med.uni-marburg.de
authors: K
authors: K
authors: Baumann
authors: J
authors: J
authors: Pfisterer
authors: P
authors: P
authors: Wimberger
authors: N
authors: N
authors: Burchardi
authors: C
authors: C
authors: Kurzeder
authors: A
authors: A
authors: du Bois
authors: S
authors: S
authors: Loibl
authors: J
authors: J
authors: Sehouli
authors: J
authors: J
authors: Huober
authors: B
authors: B
authors: Schmalfeldt
authors: I
authors: I
authors: Vergote
authors: H J
authors: HJ
authors: Lück
authors: U
authors: U
authors: Wagner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018033:Antibodies, Bispecific / Q000008:administration & dosage*; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy*
chemical_list: D018033:Antibodies, Bispecific; D009944:Organoplatinum Compounds; C522419:catumaxomab