Phase II study of ifosfamide and cisplatin for the treatment of recurrent ovarian cancer.

PURPOSE: The aim of this phase II study was to investigate the efficacy and toxicity of combined ifosfamide and cisplatin chemotherapy in patients with recurrent epithelial ovarian cancer (EOC).

EXPERIMENTAL

DESIGN

Forty-seven patients with recurrent EOC were treated with ifosfamide 5 g/m(2) and cisplatin 50 mg/m(2) on day 1, every 3 weeks for 6 cycles. The primary outcomes were response rate (RR) and toxicity. Other measurements were duration of response, time to progression (TTP), and overall survival (OS).

RESULTS

All 47 patients with 160 cycles were assessed for response and toxicity. The overall RR was 31.9 %; there were 3 complete responses (6.4 %) and 12 partial responses (25.5 %). Grade 3 and 4 hematologic toxicities included neutropenia (23.6 %), anemia (12.8 %), and thrombocytopenia (10.7 %). Non-hematologic toxicities were mild, and no drug-related toxic deaths occurred. The median duration of response, TTP, and OS was 5.1, 4.8, and 17.0 months, respectively. In the initially platinum-sensitive group, RR and OS were 44.4 % and 20.4 months, while in the initially platinum-resistant group, these values were 15.0 and 8.7 months, respectively (P = 0.027 and P = 0.002, respectively).

CONCLUSION

Ifosfamide combined with cisplatin is a well-tolerated regimen with modest activity in recurrent EOC. In addition, this regimen was especially effective in patients whose disease was initially platinum-sensitive.