![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
National Institute of Cancerología PSICOFARMA S.A.DE C.V |
---|---|
Information provided by: | National Institute of Cancerología |
ClinicalTrials.gov Identifier: | NCT00532818 |
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 | Intervention | Phase |
---|---|---|
Metastatic Cervical Cancer |
Drug: Hydralazine and magnesium valproate Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 143 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Placebo
Cisplatin + Topotecan plus placebo
|
2: Experimental |
Drug: Hydralazine and magnesium valproate
Cisplatin + Topotecan plus hydralazine valproate
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
hemoglobin >10 g/L, leukocytes >4000/mm3, platelets >100 000mm3; normal creatinine value and creatinine clearance >60 mL/min; total bilirubin < 1.5 upper normal limit value.
Exclusion Criteria:
Contact: Alfonso Dueñas-Gonzalez, MD PhD | +5255 56280486 | alfonso_duenasg@yahoo.com |
Mexico, Distrito Federal | |
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 |
Responsible Party: | Instituto Nacional de Cancerologia ( Lucely Cetina ) |
Study ID Numbers: | 006/027/ICI |
Study First Received: | September 18, 2007 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00532818 History of Changes |
Health Authority: | Mexico: Ethics Committee |
Epigenetic therapy Hydralazine Valproate |
Cervical cancer Randomized Phase III |
Vasodilator Agents Neurotransmitter Agents Tranquilizing Agents Hydralazine Psychotropic Drugs Central Nervous System Depressants Cardiovascular Agents |
Antimanic Agents Antihypertensive Agents Valproic Acid Recurrence Cisplatin Topotecan Anticonvulsants |
Vasodilator Agents Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Hydralazine Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Cardiovascular Agents Antihypertensive Agents Antimanic Agents Valproic Acid Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |