Phase II trial of combination intraperitoneal cisplatin and 5-fluorouracil in previously treated patients with advanced ovarian cancer: long-term follow-up.

Abstract

OBJECTIVES:

This trial was performed to determine the response rate and progression-free and overall survivals of patients with advanced recurrent ovarian cancer who were treated with intraperitoneal cisplatin and 5-fluorouracil.

METHODS:

Twenty-four patients with ovarian cancer were entered on this trial and treated with intraperitoneal (ip) cisplatin (DDP) and ip 5-fluorouracil, every 3 weeks for eight cycles. Following iv hydration, the cisplatin and 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 survival and toxicity analysis, and 22 patients for response. The median age was 59 (range, 35-71); initial disease status included 9 patients with residual disease following chemotherapy prior to entry on this study; 5 patients had progressed, and 10 patients had recurrent disease more than 6 months following initial chemotherapy. Of the 9 patients with residual disease, 1 complete response and 3 partial responses were observed; of 10 patients with recurrent disease, 1 complete and 1 partial response were observed for an overall response rate of 27%. No objective responses were seen in the 7 patients 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, abdominal pain, and mild anemia. Only one patient required a dosage adjustment of cisplatin for a serum creatinine elevation >2.0 mg/dl.

CONCLUSIONS:

We conclude that the combination of ip cisplatin and 5-FU is an effective regimen for patients with residual or relapsed epithelial ovarian cancer with survival durations, response rates, and toxicity profiles that compare favorably with those of other second-line ovarian cancer regimens. Patients who are primarily platinum-refractory are unlikely to benefit from these agents administered into the peritoneal cavity.

• Authors: R J Morgan Jr, P Braly, L Leong, S Shibata, K Margolin, G Somlo, M McNamara, J Longmate, S Schinke, J Raschko, S Nagasawa, N Kogut, L Najera, D Johnson, J H Doroshow
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 77 Issue 3 Pg. 433-8 (Jun 2000) ISSN: 0090-8258 [Print] United States
• PMID: 10831355 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright 2000 Academic Press.

Chemical References

• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma (drug therapy, pathology)
• Cisplatin (administration & dosage)
• Disease-Free Survival
• Fallopian Tube Neoplasms (drug therapy, pathology)
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Infusions, Parenteral
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Ovarian Neoplasms (drug therapy, pathology)
• Survival Analysis
• Treatment Outcome