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.
Dodion
P
P
Cognetti
F
F
van Rymenant
M
M
Dalesio
O
O
Kirkpatrick
A
A
Rozencweig
M
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage
D008937:Mitomycins; D005472:Fluorouracil; D006918:Hydroxyurea