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.
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
Myrna Candelaria, MD
Instituto Nacional de Cancerologia, Columbia
Mexico: Ethics Committee