Phase II study of docetaxel and topotecan combination chemotherapy in patients with advanced head and neck cancer

Purpose. To evaluate the activity of combination chemotherapy with docetaxel and topotecan in patients with advanced head and neck cancer. Methods. Docetaxel was given at 60 mg/m(2) as a 60-min intravenous infusion on day 1. Topotecan at 0.75 mg/m(2) per day was infused over 30 min on days 1, 2 and 3. Cycles were repeated every 21 days. Results. There were no responses (CR+PR) seen in the ten patients. Only one patient had stable disease and was able to receive six cycles of chemotherapy. Median survival was 81 days (range 67-161 days). Conclusions. The combination of docetaxel and topotecan at these doses and in this schedule is not recommended for patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Other investigational approaches are needed.