A Phase II Study of Carboplatin, Cisplatin, Interferon-a, and Tamoxifen for Patients with Metastatic Melanoma

Abstract

The purpose of this trial was to determine the toxicity and antineoplastic activity of cisplatin, carboplatin, tamoxifen, and interferon-α (IFN-α) in patients with advanced melanoma. Eleven patients with metastatic melanoma were enrolled. The patients received carboplatin 400 mg/m² IV on day 0; cisplatin 25 mg/m² IV on days 7, 14, and 21; tamoxifen 20 mgp.o. b.i.d. on days 0-27; and interferon-α 5 million units/m² subcutaneously 3 times per week Cycles were repeated every 28 days. Patients were assessed for tumor response at the end of 2 cycles. Toxicity was severe, with 14 of 24 cycles given requiring some form of dose reduction. Carboplatin dose reductions were related to bone-marrow toxicity, whereas IFN-α caused fatigue, arthralgias, myalgias, and fever. The overall response rate was 18% (2 partial responses [PRs]). The combination of cisplatin, carboplatin, tamoxifen, and IFN-a is active in advanced melanoma; however, the toxicity is unacceptable.