title: Randomized multicenter phase II trial of cisplatin and ifosfamide with or without paclitaxel in recurrent or metastatic carcinoma of the uterine cervix: a Hellenic Cooperative Oncology Group (HeCOG) study.
abstract: BACKGROUND
  We undertook a randomized phase II trial to test whether the addition of paclitaxel (Taxol) to the cisplatin and ifosfamide (IP) combination could improve objective response (OR) rate, progression-free survival (PFS) and overall survival (OS) in patients with recurrent or metastatic cancer of the uterine cervix.
  
  
  METHODS
  One hundred and fifty-three patients were randomly allocated to receive either the IP regimen (ifosfamide 1.5 g/m(2), daily, on days 1-3 and cisplatin 70 mg/m(2) on day 2) or the same combination with the addition of paclitaxel 175 mg/m(2) on day 1 [ifosfamide, paclitaxel and cisplatinum (ITP) regimen]. Cycles were administered every 4 weeks on an outpatient basis.
  
  
  RESULTS
  A modest increase in neurotoxicity was observed with the triplet combination. OR rate was significantly higher in the ITP group (59% versus 33%, P = 0.002). Median PFS was 7.9 and 6.3 months for patients in the ITP and IP arms, respectively (P = 0.023). Median OS was 15.4 months and 13.2 months in the ITP and IP arms, respectively (P = 0.048). In multivariate analysis, the triplet yielded a hazard ratio of 0.70 for relapse or progression (P = 0.046) and 0.75 for death (P = 0.124) compared with the doublet.
  
  
  CONCLUSIONS
  The ITP combination merits further investigation in randomized phase III studies.
authors.affiliation: Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece.
authors.forename: G
authors.initials: G
authors.lastname: Mountzios
authors.forename: M A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: A
authors.initials: A
authors.lastname: Bamias
authors.forename: G
authors.initials: G
authors.lastname: Vourli
authors.forename: H
authors.initials: H
authors.lastname: Kalofonos
authors.forename: G
authors.initials: G
authors.lastname: Aravantinos
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
authors.forename: C A
authors.initials: CA
authors.lastname: Papadimitriou
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D015080:Mesna / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D015080:Mesna; D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide