Hydralazine Valproate for Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT00533299|
Recruitment Status : Unknown
Verified August 2007 by National Institute of Cancerología.
Recruitment status was: Recruiting
First Posted : September 21, 2007
Last Update Posted : September 21, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Hydralazine and magnesium valproate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||211 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||August 2007|
|Estimated Study Completion Date :||December 2009|
Topotecan hydralazine valproate
Drug: Hydralazine and magnesium valproate
Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 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.
Placebo Comparator: 2
Placebo, hydralazine, valproate
Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.
- Progression-Free Survival [ Time Frame: 2-years ]
- Safety, response, overall survival. [ Time Frame: 2-years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533299
|Contact: Alfonso Dueñas-Gonzalez, MD PhD||+5255 56280486|
|Instituto Nacional de Cancerologia||Recruiting|
|Mexico City, Tlalpan, Mexico, 14080|
|Principal Investigator: Dolores Gallardo, MD|
|Principal Investigator:||Dolores Gallardo, MD||Instituto Nacional de Cancerologia, Columbia|