PHASE-II TRIAL OF 5-FU ADMINISTERED IP TO PATIENTS WITH REFRACTORY OVARIAN-CANCER

  • 1 January 1984
    • journal article
    • research article
    • Vol. 68  (10) , 1229-1232
Abstract
A phase II study of i.p. 5-FU [5-fluorouracil] was performed in 14 patients with ovarian cancer who were refractory to systemic chemotherapy including prior i.v. 5-FU in 12 of the patients. 5-FU was administered via a semipermanent Tenckhoff peritoneal dialysis catheter. The starting concentration of 5-FU in the dialysate was 4 mM. The patients received 8 consecutive 2-l exchanges, each of 4 h duration, for a total of 36 h including time for instillation and drainage. Treatment courses were repeated every 2 wk for 6 cycles or until disease progression occurred. A total of 69 cycles of i.p. 5-FU were administered to 14 patients. There was 1 complete response to therapy documented by 2nd-look laparotomy. While the response rate was only 7%, in 7 of 8 (88%) patients with small volume disease (tumor masses < 2.0 cm in diameter), there was no evidence for disease progression while receiving i.p. 5-FU therapy. In this phase II trial, the major toxic effect of i.p. 5-FU was abdominal pain. While there were no cases of documented bacterial peritonitis, all of the patients experienced some degree of abdominal discomfort while receiving therapy. Fifty percent of the patients had severe abdominal pain with at least 1 cycle of therapy. Other toxic effects included myelosuppression, mucositis, nausea and vomiting, and skin rash. I.p. 5-FU should be further evaluated in patients with ovarian cancer who have a small volume of disease and who have not had prior therapy with 5-FU.