A phase I study of cisplatin, methotrexate, levofolinic acid and 5- fluorouracil in advanced squamous cell carcinoma of the head and neck

Francesco Caponigro, Pasquale Comella, Antonio Daponte, Adriano Gravina, Giacomo Carteni, Maria Biglietto, Rossana Casaretti, Giuseppe Frasci, Franco Ionna, Nicola Mozzillo, Giuseppe Comella

Research output: Contribution to journalArticle


Twenty-one chemotherapy-naive patients with unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) received a combination chemotherapy including cisplatin (CDDP), methotrexate (MTX), folinic acid (LFA) and 5-fluorouracil (5-FU). The doses of the 3 cytotoxic drugs were escalated until dose-limiting toxicity occurred in more than 1/3 of the patients. The treatment was generally well tolerated; no toxic deaths occurred. Only 2 patients showed dose-limiting neutropenia. Non-haematologic drug toxicities were infrequent and never reached grade 3. 3/21 (14%) complete responses and 6/21 (29%) partial responses were observed, for an overall response rate of 43%. 5/6 patients treated at step 5 achieved an objective response to treatment and 2 complete responses were observed in this group of patients. Although maximum tolerated doses (MTD) were not reached even at step 5, we decided to stop the escalation and to recommend this level for the phase II study. Our regimen combines a good tolerability with a high level of activity at step 5; a phase II study is currently ongoing.

Original languageEnglish
Pages (from-to)1207-1211
Number of pages5
JournalOncology Reports
Issue number6
Publication statusPublished - Nov 1997



  • 5-fluorouracil
  • Cisplatin
  • Folinic acid
  • Head and neck cancer
  • Methotrexate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this