Randomized, Double-Blind, Phase III Trial of Chemotherapy Plus the Transcriptional Therapy Hydralazine and Magnesium Valproate Versus Chemotherapy Plus Placebo in Cisplatin-Resistant Recurrent Ovarian Cancer.
Randomized, double-blind phase III trial. A total of 211 patients (alpha 0.5, power 0.8)with
cisplatin-resistant recurrent or persistent cancer will be randomized to topotecan + placebo
or topotecan + hydralazine + valproate for 6 courses every 4 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
Dolores Gallardo, MD
Instituto Nacional de Cancerologia, Columbia
Mexico: Ethics Committee