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Hydralazine Valproate for Ovarian Cancer

NCT ID: NCT00533299

Last Updated: 2007-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-12-31

Brief Summary

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The current standard for recurrent, persistent or metastatic cisplatin-resistant ovarian cancer is palliative chemotherapy with either topotecan, liposomal doxorubicin or gemcitabine, 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 topotecan over placebo plus topotecan upon progression-free survival.

Hypothesis. Hydralazine and magnesium valproate associated to topotecan will increase progression-free survival from 6 to 9 months as compared with the same regimen of chemotherapy plus placebo.

Detailed Description

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Randomized, double-blind phase III trial. A total of 211 patients (alpha 0.5, power 0.8)with cisplatin-resistant recurrent or persistent cancer will be randomized to topotecan + placebo or topotecan + hydralazine + valproate for 6 courses every 4 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.

Conditions

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Ovarian Cancer

Keywords

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Epigenetics, hydralazine, valproate, ovarian cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Topotecan hydralazine valproate

Group Type EXPERIMENTAL

Hydralazine and magnesium valproate

Intervention Type DRUG

Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 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.

2

Placebo, hydralazine, valproate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.

Interventions

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Hydralazine and magnesium valproate

Hydralazine and valproate will start from seven days before day 1 of chemotherapy until the end of the sixth course. Hydralazine will be administered at 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.

Intervention Type DRUG

Placebo

Placebos will start from seven days before day 1 of chemotherapy until the end of the sixth course. Placebo tablets will be administered in an identical form that experimental drugs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Measurable or evaluable disease(evaluable according to CA125 criteria of GCIG) Cisplatin resistant ovarian cancer
* Persistent or progression to first line platinum-based chemotherapy
* Relapse within 6 months after completing first line platinum-based chemotherapy
* Platinum-sensitive disease who are failed to second line therapy based on platinum.
* Adequate organic 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Cancerología

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Dolores Gallardo, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerologia, Columbia

Locations

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Instituto Nacional de Cancerologia

Mexico City, Tlalpan, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Alfonso Dueñas-Gonzalez, MD PhD

Role: CONTACT

Phone: +5255 56280486

Other Identifiers

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006/028/DDI

Identifier Type: -

Identifier Source: org_study_id