A clinical trial of intravenous vinorelbine tartrate plus tamoxifen in thetreatment of patients with advanced malignant melanoma

BACKGROUND. The aim of the current trial was to assess the efficacy and tox icity of weekly intravenous vinorelbine tartrate with daily oral tamoxifen in the treatment of patients with advanced or metastatic malignant melanoma . METHODS. Thirty-one patients were treated with vinorelbine tartrate, 30 mg/ m(2) intravenously, weekly every 13 weeks and then every 2 weeks thereafter until progression of disease or severity of toxicity warranted discontinua tion. Tamoxifen, 10 mg orally, twice a day was administered daily starting on Day 1 of chemotherapy with vinorelbine tartrate. Thirty patients had cut aneous melanoma with metastases and 1 patient had ocular melanoma with meta stases. Eight patients had received prior chemotherapy. RESULTS. Of the 30 evaluable patients with cutaneous melanoma, 6 achieved a partial response, for an overall response rate of 20% (95% confidence inte rval, 7-38%). There was no response in the patient with ocular melanoma. Ma jor sites of response include the adrenal gland, lung, tonsil, and cutaneou s/subcutaneous tissues. Three patients had a prolonged duration of response lasting greater than or equal to 12 months. Side effects generally were mi ld and tolerable. Grade 3 or 4 hematologic toxicity occurred in 26% and 13% of patients, respectively. Nonhematologic toxicity included mild fatigue, paresthesia, and local arm discomfort from infusion. CONCLUSIONS. Weekly intravenous vinorelbine tartrate plus daily oral tamoxi fen appears to be active in the treatment of patients with malignant melano ma. Further clinical trials in malignant melanoma patients treated with vin orelbine tartrate and tamoxifen appear warranted. (C) 2000 American Cancer Society.