Cisplatin, 5-Fluorouracil and high dose oral Leucovorin (PFL) with Methotrexate and Piritrexim as Neo-Adjuvant chemotherapy for head and neck cancer

Studies in head and neck cancer at the University of Chicago have focused on the biochemical modulation of 5-Fluorouracil (5-FU). This has included the addition of high dose oral Leucovorin to the combination of Cisplatin and continuous infusion 5-FU (PFL). After establishing the pattern of toxicities, the recommended doses, and the efficacy of PFL in recurrent and/or metastatic disease [1], we treated patients with locally advanced disease with this PFL regimen and identified a high degree of activity [2, 3]. Piritrexim (PTX) is a MTX-analogue with single agent activity in head and neck cancer [4]. Since it is lipid soluble, it requires no active transportation and, therefore, may be able to overcome transport-related MTX resistance. In this phase II study, we added MTX and PTX to the PFL regimen (PFL-MP) hoping to further increase its activity.