Phase II study of a combination of hydroxyurea, fluorouracil and mitomycin in previously treated squamous cell carcinoma of the head and neck

Thirty-six evaluable patients with locoregionally recurrent or metastatic squamous cell carcinoma of the head and neck were treated with a combination of mitomycin (10 mg/m² i.v. day 1), fluorouracil (500 mg/m² i.v. days 1 + 8) and hydroxyurea (1 g/m² orally days 2-14). Thirty-three patients had received prior radiation therapy and 34 prior chemotherapy. Only two patients exhibited a partial response. Hematological toxicity was substantial, with three patients experiencing leukopenia below 1000/mm³ and seven patients experiencing thrombocytopenia below 25,000/mm³. There were four cases of treatment-related bleeding and one infection. Other side-effects were mild to moderate. Low antitumor activity and substantial toxicity preclude further evaluation of this regimen in head and neck cancer.