Hydralazine Valproate for Cervical Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00532818|
Recruitment Status : Unknown
Verified March 2009 by National Institute of Cancerología.
Recruitment status was: Recruiting
First Posted : September 20, 2007
Last Update Posted : March 30, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cervical Cancer||Drug: Hydralazine and magnesium valproate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 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 Recurrent and Metastatic Cervical Cancer.|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||December 2010|
|Placebo Comparator: 1||
Cisplatin + Topotecan plus placebo
Other Name: TRANSKRIP R/L
Drug: Hydralazine and magnesium valproate
Cisplatin + Topotecan plus hydralazine valproate
Other Name: TRANSKRIP R/L
- Progression-free survival [ Time Frame: 2-years ]
- Response rate, safety, overall survival. [ Time Frame: 2-years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532818
|Contact: Alfonso Dueñas-Gonzalez, MD PhD||+5255 firstname.lastname@example.org|
|Instituto Nacional de Cancerologia||Recruiting|
|Mexico City, Distrito Federal, Mexico, 14080|
|Principal Investigator: Lucely Cetina, MD|
|Study Chair:||Myrna Candelaria, MD||Instituto Nacional de Cancerologia, Columbia|