The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian
cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or
gemcitabine, however, the results need to be improved. Epigenetic aberrations play an
important role in cancer progression by silencing growth regulatory genes and there is now
evidence that inhibitors of DNA methylation and HDAC inhibition synergize the cytotoxicity of
chemotherapy.
Objective. To determine the superiority of epigenetic therapy with hydralazine and valproate
plus topotecan over placebo plus topotecan upon progression-free survival.
Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase
progression-free survival from 6 to 9 months as compared with the same regimen of
chemotherapy plus placebo.