A phase III randomized trial of dacarbazine and carboplatin with and without tamoxifen in the treatment of patients with metastatic melanoma

✍ Scribed by Sanjiv S. Agarwala; William Ferri; William Gooding; John M. Kirkwood

• Publisher: John Wiley and Sons
• Year: 1999
• Tongue: English
• Weight: 90 KB
• Volume: 85
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19990501)85:9<1979::aid-cncr15>3.0.co;2-g

✦ Synopsis

BACKGROUND.

Metastatic melanoma is a disease associated with a poor prognosis, and dacarbazine is still the reference agent. The authors conducted a randomized trial to test the benefit of adding tamoxifen to dacarbazine and carboplatin chemotherapy for previously untreated patients with metastatic melanoma.

METHODS.

Eligible patients with histologically confirmed, measurable metastatic melanoma were randomized to carboplatin 300 mg/m 2 and dacarbazine 1 g/m 2 administered intravenously on Day 1 with or without tamoxifen 20 mg/day administered orally throughout the treatment period (C ϩ D Ϯ T). Chemotherapy was repeated in 28-day treatment cycles for a minimum of 2 cycles or until disease progression. The study was designed to be stopped after accrual of 28 patients per treatment arm based on 80% power to detect an improvement in response from 20% to 40% among patients treated with tamoxifen.