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Hydralazine Valproate for Cervical Cancer

NCT00532818 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2009-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Cervical Cancer

Interventions

DRUG

Hydralazine and magnesium valproate

Cisplatin + Topotecan plus hydralazine valproate

DRUG

Placebo

Cisplatin + Topotecan plus placebo

Sponsors & Collaborators

  • Psicofarma S.A. de C.V.

    collaborator OTHER

  • National Institute of Cancerología

    lead OTHER_GOV

Principal Investigators

  • Myrna Candelaria, MD · Instituto Nacional de Cancerologia, Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • Mexico

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00532818 on ClinicalTrials.gov