The current standard for recurrent, persistent or metastatic cervical cancer is palliative
chemotherapy with cisplatin topotecan, 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 standard cisplatin topotecan against placebo plus cisplatin topotecan upon
progression-free survival.
Hypothesis. Hydralazine and magnesium valproate associated to cisplatin topotecan will
increase progression-free survival from 4.6 to 7.6 months as compared with the same regimen
of chemotherapy plus placebo.