Advanced ovarian carcinoma: a prospective and randomized clinical trial of cyclophosphamide versus combination cytotoxic chemotherapy (Hexa-CAF).

Fifty-seven evaluable patients with advanced ovarian carcinoma were randomized to receive either a combination of hexamethylmelamine, cyclophosphamide, methotrexate and 5-fluorouracil (Hexa-CAF) or high-dose cyclophosphamide alone given intravenously intermittently. Objective responses were seen in 62% of patients receiving cyclophosphamide alone, and 36% of patients in the Hexa-CAF regimen, this difference being statistically significant (P less than 0.05). The median duration of objective response (10 months vs. 9 months) and the median survival (11 months vs. 10 months) were greater in the cyclophosphamide group, but these differences were not statistically significant. It is concluded that there is no therapeutic advantage for the Hexa-CAF protocol over the alkylating agent used alone.