PHASE-II STUDY OF HIGH-DOSE CISPLATIN, ETOPOSIDE, AND CYCLOPHOSPHAMIDE FOR REFRACTORY OVARIAN-CANCER

OBJECTIVES: A phase II trial of high-dose cyclophosphamide, etoposide, and cisplatin was done. STUDY DESIGN: Forty-eight patients with progr essive 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/m(2)), etoposide (750 mg/m(2)) , and cisplatin (120 mg/m(2)). RESULT: Seventy-four cycles were delive red. Six patients died during treatment (12.5%). Of 28 with measurable disease, there was a 25% response rate and 32% had stable disease. Me dian time to recurrence and survival were significantly different for minimal versus bulky disease (p = 0.0089, p = 0.0008, log-rank) and fo r platinum-sensitive Versus platinum-resistant disease (p = 0.18, p = 0.0012, log-rank). The number of prior regimens was not correlated wit h lime to progression or survival. CONCLUSION: This study shows little advantage for high-dose protocols except for patients with a response to platinating agents and minimal residual disease.