title: Phase II study of the combination carboplatin plus celecoxib in heavily pre-treated recurrent ovarian cancer patients.
abstract: BACKGROUND
  Cyclooxygenase-2 overexpression is associated with poor outcome and resistance to platinum-based chemotherapy in ovarian cancer. We evaluated the antitumor activity and safety of the combination carboplatin plus the COX-2 inhibitor celecoxib in recurrent heavily-treated OC patients.
  
  
  METHODS
  Patients were administered oral celecoxib (400 mg/day) in combination with intravenous carboplatin (AUC5, q28). A Simon's two-stage design was employed.
  
  
  RESULTS
  45 patients were enrolled: 23 (51.1%) presented platinum-resistance, and 27 (60%) had received at least 3 prior regimens for recurrence. The response rate was 28.9% with 3 complete and 10 partial responses (median duration of response = 6 months). Only one (0.4%) G4 non-febrile neutropenia was observed; G3 neutropenia, anemia, or thrombocytopenia, were observed in 2.5%, 1.7%, and 1.7% of the cycles, respectively. G3-4 vomiting was reported in only 1.7%, and 0.4% of the cycles were associated with G3 dyspepsia or diarrhea or constipation. Only one patient experienced G3 hypertension associated to G2 hypersensitivity reaction. No differences in baseline versus post-treatment Quality of Life scores were observed. Median progression free survival and overall survival were 5 and 13 months, respectively.
  
  
  CONCLUSIONS
  Celecoxib combined with carboplatin showed promising activity and it is well tolerated in heavily-treated recurrent ovarian cancer patients.
  
  
  BACKGROUND
  NCT01124435 (ClinicalTrials.gov Identifier) and 935/03 (study ID numbers).
authors.affiliation: Gynecologic Oncology Unit, Catholic University of Campobasso, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Legge
authors.forename: Amelia
authors.initials: A
authors.lastname: Paglia
authors.forename: Marco
authors.initials: M
authors.lastname: D'Asta
authors.forename: Gilda
authors.initials: G
authors.lastname: Fuoco
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D000068579:Celecoxib; D043169:Endostatins / Q000097:blood; D005260:Female; D006801:Humans; D008875:Middle Aged; D009389:Neovascularization, Pathologic / Q000097:blood; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011720:Pyrazoles / Q000008:administration & dosage; D011788:Quality of Life; D012008:Recurrence; D013449:Sulfonamides / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D043169:Endostatins; D011720:Pyrazoles; D013449:Sulfonamides; D042461:Vascular Endothelial Growth Factor A; D016190:Carboplatin; D000068579:Celecoxib