Hydralazine Valproate for Cervical Cancer

NCT00532818 | Unknown Phase 3 DMC

• 1 other identifier: 006/027/ICI
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Epigenetic therapy; Hydralazine; Valproate; Cervical cancer; Randomized; Phase III

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2-years

Secondary Outcomes (1)

• Response rate, safety, overall survival.

  2-years

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: Hydralazine and magnesium valproate

Interventions

Hydralazine and magnesium valproate DRUG

Cisplatin + Topotecan plus hydralazine valproate

Also known as: TRANSKRIP R/L

2

Placebo DRUG

Cisplatin + Topotecan plus placebo

Also known as: TRANSKRIP R/L

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Psicofarma, S.A. De C.V.: collaborator

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Hydralazine; Valproic Acid

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Myrna Candelaria, MD

  Instituto Nacional de Cancerologia, Columbia

  STUDY CHAIR

Central Study Contacts

Alfonso Dueñas-Gonzalez, MD PhD

CONTACT

+5255 56280486; alfonso_duenasg@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 20, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 30, 2009

Record last verified: 2009-03

Locations

ME (1)