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Phase III Clinical Trial of the Combination of Cisplatin, Dacarbazine, and Carmustine With or Without Tamoxifen in Patients With Advanced Malignant Melanoma

From the Mayo Clinic and Mayo Foundation, Rochester, and Duluth Community Clinical Oncology Program, Duluth, MN; Illinois Oncology Research Association CCOP, Peoria, and Carle Cancer Center Community Clinical Oncology Program, Urbana, IL; and Siouxland Hematology-Oncology Associates, Sioux City, IA.

Address reprint requests to Edward T. Creagan, MD, Mayo Clinic, 200 First St, SW, Rochester, MN 55905; email creagan.edward{at}mayo.edu

PURPOSE: A prospective randomized phase III clinical trial was conducted to assess whether the addition of tamoxifen (TAM) to the three-agent regimen of cisplatin (CDDP), dacarbazine (DTIC), and carmustine (BCNU) significantly increased the progression-free survival and overall survival of patients with advanced malignant melanoma.

PATIENTS AND METHODS: Patients with advanced malignant melanoma were treated with CDDP + DTIC + BCNU (CDB) with or without TAM. The dose schedule was CDDP 25 mg/m² given intravenously (IV) for 30 to 45 minutes in 500 mL of dextrose and normal saline (NS) on days 1 to 3 of a 3-week cycle; DTIC 220 mg/m² IV for 1 hour in 500 mL of dextrose and NaCl on days 1 to 3 of a 3-week cycle; BCNU 150 mg/m² IV for 2 to 3 hours in 750 to1,000 mL of dextrose and 5% water onday 1 of every odd 3-week cycle; and TAM 20 mg taken orally every morning.

RESULTS: There were 184 eligible patients enrolled. These patients were observed until death or for a minimum of 1.3 years. At last contact, 12 were still alive. The median time to progression was 3.4 months on the CDB arm and 3.1 months on the CDB + TAM arm. The median survival time was 6.8 months with CDB and 6.9 months with CDB + TAM. Progression-free survival (P = .429) and overall survival (P = .545) were not found to differ by treatment.

CONCLUSION: The addition of TAM to this three-agent regimen of CDB was not found to provide a meaningful clinical advantage in the treatment of patients with advanced malignant melanoma.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic, and was supported in part by United States Public Health Service grants no. CA-25224, CA-37404, CA-15083, CA-35113, CA-35195, CA-35269, CA-35103, CA-35101, CA-37417, CA-35272, CA-35415, CA-52352, CA-60276, CA-63848, and CA-63849 from the National Cancer Institute, Department of Health and Human Services.

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