Phase II study of high-dose cisplatin, etoposide, and cyclophosphamide for refractory ovarian cancer.

Abstract

A phase II trial of high-dose cyclophosphamide, etoposide, and cisplatin was done. Forty-eight patients with progressive or persistent disease and previous cisplatin-based chemotherapy and no paclitaxel therapy were entered for treatment on the basis of two cycles of cyclophosphamide (4500 mg/m2), etoposide (750 mg/m2), and cisplatin (120 mg/m2). Seventy-four cycles were delivered. Six patients died during treatment (12.5%). Of 28 with measurable disease, there was a 25% response rate and 32% had stable disease. Median time to recurrence and survival were significantly different for minimal versus bulky disease (p = 0.0089, p = 0.0008, log rank) and for platinum-sensitive versus platinum-resistant disease (p = 0.18, p = 0.0012, log-rank). The number of prior regimens was not correlated with time to progression or survival. This study shows little advantage for high-dose protocols except for patients with a response to platinating agents and minimal residual disease.