Results of randomised phase II studies comparing S16020 with methotrexate in patients with recurrent head and neck cancer

X. Pivot, A. Awada, D. Gedouin, J. Kerger, F. Rolland, D. Cupissol, F. Caponigro, G. Comella, J. J. Lopez-Pouza, E. Guardiola, B. Giroux, B. Gérard, M. Schneider

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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. Patients and 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.

Original languageEnglish
Pages (from-to)373-377
Number of pages5
JournalAnnals of Oncology
Issue number3
Publication statusPublished - Mar 1 2003


  • Head and neck squamous cell carcinoma
  • Methotrexate
  • Randomised trial
  • Recurrence
  • S16020

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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