Phase II trial of combination intraperitoneal cisplatin and 5-fluorouracilin previously treated patients with advanced ovarian cancer: Long-term follow-up

Objectives. This trial was performed to determine the response rate and pro gression-free and overall survivals of patients with advanced recurrent ova rian cancer who were treated with intraperitoneal cisplatin and 5-fluoroura cil. Methods. Twenty-four patients with ovarian cancer were entered on this tria l and treated with intraperitoneal (ip) cisplatin (DDP) and ip 5-fluorourac il, every 3 weeks for eight cycles. Following iv hydration, the cisplatin a nd 5-fluorouracil were administered through an ip catheter in 2 liters of 0 .9% normal saline with a 4-h dwell. Results. All patients were evaluable for progression-free and overall survi val and toxicity analysis, and 22 patients for response. The median age was 59 (range, 35-71); initial disease status included 9 patients with residua l disease following chemotherapy prior to entry on this study; 5 patients h ad progressed, and 10 patients had recurrent disease more than 6 months fol lowing initial chemotherapy. Of the 9 patients with residual disease, 1 com plete response and 3 partial responses were observed; of 10 patients with r ecurrent disease, 1 complete and 1 partial response were observed for an ov erall response rate of 27%. No objective responses were seen in the 7 patie nts who were platinum-refractory on protocol entry. The median progression- free and overall survivals are 7.0 (range, 0.5-137) and 15.5 (range, 3-147) months, respectively. Toxicity included hypomagnesemia, vomiting, abdomina l pain, and mild anemia. Only one patient required a dosage adjustment of c isplatin for a serum creatinine elevation >2.0 mg/dl. Conclusions. We conclude that the combination of ip cisplatin and 5-FU is a n effective regimen for patients with residual or relapsed epithelial ovari an cancer with survival durations, response rates, and toxicity profiles th at compare favorably with those of other second-line ovarian cancer regimen s. Patients who are primarily platinum-refractory are unlikely to benefit f rom these agents administered into the peritoneal cavity. (C) 2000 Academic Press.