Objective: To evaluate the anti-tumour activity and toxicity of ifosfa
mide (5 g/m(2) continuous infusion) and mitoxantrone (10 mg/m(2)) give
n in combination every 3 weeks in patients with ovarian cancer resista
nt to at least two previous regimens which included platinum. Patients
and methods: Additional eligibility criteria were an ECOG performance
status less than or equal to 2 and measurable disease. Of 47 patients
entered in the study, 8 were defined as platinum-resistant and 39 as
potentially sensitive according to Markman's criteria. Thirty-five pat
ients had also received paclitaxel as last treatment before entering t
his study. Tumour response was evaluated every three cycles. Results:
One complete and 11 partial responses were reported, for an overall re
sponse rate of 25% (95% CI: 14%-40%). Three of the partial responders
were resistant to platinum. None of the 7 partial responders pretreate
d with taxol had responded to it. The overall median survival was 11 m
onths. Neutropenia G4 was reported in 18 patients (42%) with hospitali
sation because of febrile neutropenia in 3 of them. Conclusions: In pa
tients with ovarian cancer failing at least 2 previous therapies inclu
ding platinum, the combination of ifosfamide and mitoxantrone has show
n an anti-tumour activity comparable to that of paclitaxel, with accep
table toxicity. Objective responses were reported also in patients fai
ling paclitaxel, suggesting a lack of cross resistance.