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 melanom a and no prior chemotherapy were treated with docetaxel 100 mg m(-2) a dministered intravenously over 1 hour every 21 days. Patients were pre medicated prior to each course with dexamethasone and diphenhydramine. Toxicity and follow-up were provided. Objective responses were seen i n two out Of 35 patients evaluable for response, one complete response and one partial response. These two responses were of a duration of g reater than two years. The most common toxicity was grade 4 neutropeni a, which occurred in 92% of patients; 49% required hospitalization for an episode of neutropenic fever. Additional patients had reversible g rade 3-4 toxicities including nausea, vomiting, diarrhea, stomatitis, arthralgias, myalgias, peripheral neuropathy and fatigue. Eighteen pat ients had hypersensitivity reactions, two were grade 3-4. Fluid retent ion, grade 1-3 was observed in seven patients. Alopecia occurred in mo st patients. Docetaxel has definite but low-level activity against mal ignant melanoma. Further investigation of this drug should be consider ed in multidrug combination programs.