Moderate-dose cyclophosphamide for disseminated ovarian carcinoma: a phase II study.

Fifty-six evaluable patients with advanced ovarian carcinoma (FIGO III or IV), without prior cytotoxic chemotherapy, were studied to assess the activity of single-agent moderate-dose cyclophosphamide, 40 mg/kg to a maximum dose of 3000 mg, given intravenously as a bolus injection every 3 weeks. All patients were treated as outpatients. Moderate-dose cyclophosphamide resulted in 36 (64%) objective responses (19 CR, 17 PR). Nausea and severe vomiting occurred in all patients, but no patient needed hospitalization for this complication. Other side-effects observed were alopecia (100%), leukocytes less than or equal to 2500/microliters (18%), chemical cystitis (11%) and sepsis (4%). The median duration of response was 11 months, and the estimated median survival by the life-table method for responders was 16 months and for non-responders 4 months (P less than 0.001). Clinical trials previously performed by our group comparing cyclophosphamide alone, either vs cis-platinum, adriamycin and hexamethylmelamine or vs Hexa-CAF, showed a better remission rate with the use of moderate-dose cyclophosphamide alone. Therefore we suggest further investigation of this agent in a moderate dose in disseminated ovarian carcinoma.