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Papadopoulos NE et al. – Cisplatin-paclitaxel-dacarbazine regimen is effective in patients with advanced melanoma.

Methods

Chemotherapy-naive patients with surgically unresectable stage III/IV melanoma who had measurable lesions, no brain metastasis, and an Eastern Oncology Cooperative Group performance status of 0 or 1 enrolled
Cohorts of 4 patients treated at each dose level
Starting doses of drugs were as follows: cisplatin 20 mg/m2 IV on days 1 to 4, paclitaxel 100 mg/m2 IV on days 1 and 8, and dacarbazine 800 mg/m2 IV on day 1 only
Doses of cisplatin and paclitaxel escalated to next dose level, until maximum tolerable doses reached
Dose level without dose-limiting grade 4 toxicity chosen for phase II part of study
Primary end point of phase II study to determine antitumor activity in terms of response rate and survival of patients

Results

Optimum chemotherapy doses for phase II study as follows: cisplatin 20 mg/m2 on days 1 to 4, paclitaxel 120 mg/m2 on days 1 and 8, and dacarbazine 800 mg/m2 on day 1
46 patients enrolled
2 complete and 17 partial responses seen for overall response rate of 41%
Median overall survival time and time to tumor progression were 11.0 and 4.3 months
Median response duration 6.2 months
Myelosuppression and neuropathy were dose-limiting toxicities