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Hydralazine Valproate for Cervical Cancer

Information source: National Institute of Cancerología
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Cervical Cancer

Intervention: Hydralazine and magnesium valproate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute of Cancerología

Official(s) and/or principal investigator(s):
Myrna Candelaria, MD, Study Chair, Affiliation: Instituto Nacional de Cancerologia, Columbia

Overall contact:
Alfonso Dueñas-Gonzalez, MD PhD, Phone: +5255 56280486, Email: alfonso_duenasg@yahoo.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome: Response rate, safety, overall survival.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- informed consent, histological diagnosis of persistent, recurrent or metastatic

cervical carcinoma; measurable disease by physical examination, CT Scan, MRI or PET-CT. Biopsy is required for confirmation only if the lesion is unique, has less than 2cm in the longest diameter or has no clearly defined borders.

- Patients should have no previous systemic treatment (could have received chemotherapy

as radiosensitization to the pelvis and or para-aortic field.

- Aged >18 years, performance status 0-2 according to ECOG classification, and adequate

liver, hematological and renal function, as defined by: 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:

- History of allergy to hydralazine or valproate; past or present condition of

rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician; newly diagnosed hypertension patients with or without pharmacological treatment are allowed as long as their treatment do not include hydralazine.

- Previous use of the experimental drugs (hydralazine and magnesium valproate) as well

as if patients were pregnant or breast-feeding. Other exclusion criteria are uncontrolled systemic disease or infection.

Locations and Contacts

Alfonso Dueñas-Gonzalez, MD PhD, Phone: +5255 56280486, Email: alfonso_duenasg@yahoo.com

Instituto Nacional de Cancerologia, Mexico City, Distrito Federal 14080, Mexico; Recruiting
Lucely Cetina, MD, Principal Investigator
Additional Information

Starting date: July 2007
Last updated: March 27, 2009

Page last updated: November 27, 2014

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