Current and future trials of Taxol (paclitaxel) in head and neck cancer

Phase II clinical trials of single-agent paclitaxel have demonstrated the drug's activity in ovarian cancer, breast cancer, and both small cell and non-small cell lung cancer. A recently completed trial in recurrent head and neck cancerpatients conducted by the Eastern Cooperative Oncology Group resulted in a 40% (12 of 30) overall (complete plus partial) response rate with a high dose of paclitaxel (250 mg/m2 by 24-hour continuous infusion) and granulocyte colony-stimulating factor support. Responses were observed in previously irradiated sites of locoregional disease as well as in distant metastases. The major toxicities were brief grade 3-4 neutropenia occurring in 91%, peripheral neuropathy in 39%, and arthralgias/myalgias in 39% of treated patients. Confirmatory single-agent trials with paclitaxel are in progress in the United States and Europe. Phase I and II trials also in progress or planned combine paclitaxel with cisplatin or carboplatin; ifosfamide; methotrexate; and cisplatin/5-fluorouracil. Lower doses (135 to 175 mg/m2) and alternative infusion schedules ranging from 3 hours to 10 days are also under evaluation in head and neck cancer and other solid tumors. Studies combining paclitaxel and radiotherapy are reviewed as well.