Evaluation of gemcitabine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: A Southwest Oncology Group Phase II study

A phase II trial of gemcitabine (Gemzar(R)), a nucleoside analogue with bro ad activity in solid tumors, was performed in patients with recurrent or me tastatic squamous cell carcinoma of the head and neck. A total of 26 eligib le patients were registered to receive a dose of 1250 mg/m(2) weekly for 3 weeks, followed by a 1 week rest. Toxicity was evaluable in 26 patients. Na usea and vomiting occured in 11 and 6 patients, repectively. Grade 3 or 4 h ematologic toxicities were infrequent. Two patients developed neutropenic i nfections. One patient developed fatal liver failure which was thought due to progressive liver metastases or infection 14 days after a single dose of gemcitabine. There were no objective treatment responses (95% CI 0-13%), w ith a median survival of 6 months in this highly resistant disease populati on. Gemcitabine is not considered active enough as monotherapy for further evaluation in this disease population.