title: Results of randomised phase II studies comparing S16020 with methotrexate in patients with recurrent head and neck cancer.
abstract: BACKGROUND
  The purpose of this study was to carry out two randomised phase II trials of S16020, a new olivacine derivative, tested as a single agent in patients with recurrent head and neck cancer, using methotrexate as the control arm to validate the results.
  
  
  METHODS
  S16020 at either 80 or 100 mg/m2 was administered as a 3-h infusion every 3 weeks. Methotrexate, 40 or 50 mg/m2, was given by bolus injection, weekly for a minimum of 6 weeks. In total, 36 patients were entered in the randomised studies (25 in an initial study, 11 in a confirmatory study) of whom 24 received S16020 and 12 received methotrexate.
  
  
  RESULTS
  A scheduled interim analysis showed one patient having a non-confirmed objective response with S16020 and three patients having a confirmed objective response with methotrexate. In the methotrexate group, there were no patients with severe non-haematological toxicity. With S16020, there was a high incidence of severe non-haematological toxicities, including asthenia, oedema of the face, oedema and pain at the tumour sites and erythematous rash; consequently, both studies were stopped.
  
  
  CONCLUSIONS
  Both studies were stopped due to the poor anticipated benefit/risk ratio for S16020, although time to progression and overall survival time were similar in both treatment arms.
authors.affiliation: Service d'Oncology, CHU J. Minjoz, Besançon, France. xpivot@chu-besancon.fr
authors.forename: X
authors.initials: X
authors.lastname: Pivot
authors.forename: A
authors.initials: A
authors.lastname: Awada
authors.forename: D
authors.initials: D
authors.lastname: Gedouin
authors.forename: J
authors.initials: J
authors.lastname: Kerger
authors.forename: F
authors.initials: F
authors.lastname: Rolland
authors.forename: D
authors.initials: D
authors.lastname: Cupissol
authors.forename: F
authors.initials: F
authors.lastname: Caponigro
authors.forename: G
authors.initials: G
authors.lastname: Comella
authors.forename: J J
authors.initials: JJ
authors.lastname: Lopez-Pousa
authors.forename: E
authors.initials: E
authors.lastname: Guardiola
authors.forename: B
authors.initials: B
authors.lastname: Giroux
authors.forename: B
authors.initials: B
authors.lastname: Gérard
authors.forename: M
authors.initials: M
authors.lastname: Schneider
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002227:Carbazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D004487:Edema / Q000209:etiology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D002227:Carbazoles; C117470:NSC 659687; D011725:Pyridines; D008727:Methotrexate