Phase I study of paclitaxel, cisplatin, and ifosfamide in patients with recurrent or metastatic squamous cell cancer of the head and neck.

The prognosis for patients with recurrent or metastatic squamous cell cancer of the head and neck is poor. Chemotherapy has not significantly improved survival. New agents and regimens are being developed in hopes of improving the outcome for these patients. A phase I/II trial using a combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), cisplatin, and ifosfamide is being performed. The phase I portion is completed and reported here. Granulocytopenia was the dose-limiting toxicity. Overall, the regimen was well tolerated. Major responses were observed in four of 10 evaluable patients in the phase I study. The phase II trial is ongoing.