Metastatic Cervical Cancer Clinical Trial
Official title:
Randomized, Double-Blind, Phase III Trial of Chemotherapy Plus the Transcriptional Therapy Hydralazine and Magnesium Valproate Versus Chemotherapy Plus Placebo in Recurrent and Metastatic Cervical Cancer.
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.
Randomized, double-blind phase III trial. A total of 143 patients (alpha 0.5, power 0.8)with metastatic, persistent or recurrent cervical cancer without previous systemic treatment will be randomized to cisplatin topotecan + placebo or cisplatin topotecan hydralazine valproate for 6 courses every 3 weeks. Patients will receive an oral dose of hydralazine of 182mg (rapid) or 83mg (slow) according to the acetylator phenotype in a single daily dose and magnesium valproate at an oral dose of 40mg/Kg t.i.d. Both drugs in a slow-release formulation. Experimental drugs or placebo will start from seven days before day 1 of chemotherapy until the end of the sixth course. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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