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.

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.

• Authors: X Pivot, A Awada, D Gedouin, J Kerger, F Rolland, D Cupissol, F Caponigro, G Comella, J J Lopez-Pousa, E Guardiola, B Giroux, B Gérard, M Schneider
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 14 Issue 3 Pg. 373-7 (Mar 2003) ISSN: 0923-7534 [Print] England
• PMID: 12598340 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antimetabolites, Antineoplastic
• Carbazoles
• NSC 659687
• Pyridines
• Methotrexate

Topics

• Adult
• Aged
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Carbazoles (administration & dosage, adverse effects, therapeutic use)
• Disease Progression
• Drug Administration Schedule
• Edema (etiology)
• Female
• Head and Neck Neoplasms (drug therapy, pathology)
• Humans
• Infusions, Intravenous
• Injections, Intravenous
• Male
• Methotrexate (administration & dosage, adverse effects, therapeutic use)
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Pyridines (administration & dosage, adverse effects, therapeutic use)
• Survival Analysis
• Treatment Outcome