We have performed a phase II study to evaluate the activity and toxici
ty of ifosfamide and cisplatin as first-line treatment for advanced ov
arian cancer, Patients were treated with cisplatin 100 mg/m(2) on day
1 and ifosfamide 5 g/m(2) in 18-hr continuous infusion on day 1 or 1.5
g/m(2) bolus on days 1-5. Between August 1988 and March 1990, 30 wome
n were entered in the trial, 26 of them with measurable disease, The o
verall clinical response rate was 69% (95% CI: 48-85%), including 34.6
% complete responses (95% CI:17-55%). Reassessment laparotomy was perf
ormed in 12 cases, and 4 (33%) exhibited a pathologic complete respons
e. For all patients, the median duration of progression-free survival
was 14 months, and the median overall survival was 25 months. There we
re no major differences in the response rate or survival between the t
wo ifosfamide administration modalities. Relevant toxicities were grad
e TV hematologic toxicity in 11/30 patients and grade IV renal toxicit
y in 2/30 patients. A patient with grade IV encephalopathy developed a
trauma-related cerebral hemorrhage and died 2 months later. The combi
nation of Ifosfamide and cisplatin is active in first-line therapy in
advanced ovarian cancer, although it does not seem to improve the effi
cacy or toxicity profile of conventional combinations. (C) 1997 Academ
ic Press.