Phase II trial of docetaxel (Taxotere) in patients with metastatic melanoma previously untreated with cytotoxic chemotherapy

A phase II study was undertaken to evaluate the clinical efficacy and safety of docetaxel in patients with malignant melanoma. Between April 1992 and February 1996, 37 patients with metastatic malignant melanoma and no prior chemotherapy were treated with docetaxel 100 mg m(-2) administered intravenously over 1 hour every 21 days. Patients were premedicated prior to each course with dexamethasone and diphenhydramine. Toxicity and follow-up were provided. Objective responses were seen in two out Of 35 patients evaluable for response, one complete response and one partial response. These two responses were of a duration of greater than two years. The most common toxicity was grade 4 neutropenia, which occurred in 92% of patients; 49% required hospitalization for an episode of neutropenic fever. Additional patients had reversible grade 3-4 toxicities including nausea, vomiting, diarrhea, stomatitis, arthralgias, myalgias, peripheral neuropathy and fatigue. Eighteen patients had hypersensitivity reactions, two were grade 3-4. Fluid retention, grade 1-3 was observed in seven patients. Alopecia occurred in most patients. Docetaxel has definite but low-level activity against malignant melanoma. Further investigation of this drug should be considered in multidrug combination programs.