Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck.

摘要: BACKGROUND. Patients with recurrent or metastatic HNC have a poor response and survival currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of phase II trial irinotecan cisplatin in patients HNC. METHODS. Patients were treated 65 mg/m2 IV over 90 minutes 30 administered intravenously weekly for four weeks, followed by two week rest. However, after 17 at dose mg/m2, toxicity analysis demonstrated tolerance that this patient population. protocol was amended, reduced to starting 50 mg/m2. Twenty-three additional dose. RESULTS. Forty enrolled on study between February 2002 April 2006, first level 23 amended level. Overall, 12 (71%) experienced clinically significant grade 3 4 toxicity. Twelve required reductions. Toxicity but 17% still lower dose. rate 35% 22% No complete responses noted. CONCLUSIONS. The combination is efficacious prognosis group substantial. Cancer 2008. © 2008 American Society.