Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer

NCT02446652 | Withdrawn Phase 3 DMC

• 1 other identifier: (014/037/ICI)(CEI/941/14)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety the combination of TRANSKRIP ® vs placebo plus Carboplatin/Paclitaxel as first line treatment in patients with recurrent-persistent cervical cancer.

Conditions

Cervical Cancer

Keywords

Advanced cervical cancer; Epigenetic therapy; Randomized phase III

Outcome Measures

Primary Outcomes (1)

• Overall survival

  patient´s survival since inclusion in the study until final event of death.

  24 months

Secondary Outcomes (4)

• Objective Response

  6 months

• Toxicity

  7 months

• Quality of life

  24 months

• Progression free survival

  24 months

Study Arms (2)

Hydralazine/Magnesium valproate + QT

EXPERIMENTAL

This group will receive TRANSKRIP® (Hydralazine/Magnesium valproate) + Carboplatin plus Paclitaxel

Drug: Hydralazine/Magnesium; Drug: Carboplatin; Drug: Paclitaxel

placebo + QT

PLACEBO COMPARATOR

This group will receive placebo + Carboplatin plus Paclitaxel

Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Hydralazine/Magnesium DRUG

(Hydralazine: 1 oral tablet every 24 hours, 182 mg for rapid acetylators, and 83 mg for low acetylators and Magnesium valproate: orally 30 mg/K weight every 8 hours) starting 1 week prior the first day of the QT

Also known as: TRANSKRIP ®

Hydralazine/Magnesium valproate + QT

Placebo DRUG

Placebo (orally) starting 1 week before the first day of the QT

placebo + QT

Carboplatin DRUG

5 AUC 1 hour/day 1 for every 21 days for 6 cycles

Also known as: CBP

Hydralazine/Magnesium valproate + QT; placebo + QT

Paclitaxel DRUG

175mg/m2/SC 3hour/day 1 for every 21 days for 6 cycles.

Also known as: PXL

Hydralazine/Magnesium valproate + QT; placebo + QT

Eligibility Criteria

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

You may qualify if:

• Operating status ECOG: 0-2
• Negative pregnancy test or reproduction potential is zero, determined either by surgery, radiation or menopause, or mitigated with the use of some approved contraceptive method (IUD or hormonal contraceptive during the study and at least 3 months after the study).
• Patients with histological diagnosis of persistent/recurrent cervical cancer, local and/or systemic, with disease measurable by physical examination and TAC. REQUIRED confirmation by biopsy of the recurrence or, persistence only if: lesion is single, less than 2 cm and/or has no sharp edges.
• Chemo-radiotherapy to pelvis or pelvis plus extended fields (may have received concomitant chemotherapy as a radiosensitizer) provided it is within 90 days from the last application and the secondary radiation acute effects have disappeared.
• Hemoglobin equal or greater than 9 g/L. (allowed transfusion prior to treatment to reach this hemoglobin level).
• Leukocytes greater or equal to 4000/mm3.
• Platelets equal or greater to 100 000 mm3.
• Hepatic: Total bilirubin up to 1.5 times normal value, albumin equal or greater to 2: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) lower or equal to 2.5 times the regular superior limit.
• Renal: Normal creatinine. If high, the extent debugging must be greater than 60 mL/min.
• With the exception of alopecia, patients should have resolution of all acute toxic effects of any prior surgery, radiotherapy or chemotherapy, such effects qualified according to the Common Toxicity Criteria (CTC version 3.0) from the National Cancer Institute (NCI), or within the limits shown in laboratory parameters mentioned above.
• Be willing and able to comply with the programmed visits, the treatment plan and laboratory tests.
• The ability to understand the nature of the study and give a report written consent.

You may not qualify if:

• Small cell and/or neuroendocrine cervical cancer.
• History of allergy to hydralazine, magnesium valproate or sulfa.
• Any disease of collagen present (Systemic Lupus Erythematosus (SLE), Rheumatoid arthritis (RA), etc), or history of the same.
• Recent or past condition of symptomatic postural hypotension diagnosed by a clinician.
• Secondary heart failure to aortic stenosis or any other condition where a vasodilator is contraindicated.
• Recent or past condition of active disease of the central nervous system, including seizures.
• Previous or current use of magnesium valproate and/or any other anticonvulsive.
• Pregnant patients or nursing.
• Prior cancer within the last 5 years or in presence of a second primary tumor (except carcinoma of the cervix in situ or basal cell carcinoma of the skin adequately treated).
• Use of any of the research agents in the month prior to enrollment in this study.
• Serious concomitant systemic disorders incompatible with the study at the discretion of the investigator.
• Recently receiving another onco-specific treatment research.
• Criteria Treatment Interruption
• A patient will be discontinued from the study under the following circumstances.
• If there is evidence of disease progression.

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Cancerology

Mexico City, Mexico City, 14080, Mexico

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Hydralazine; Magnesium; Carboplatin; Paclitaxel

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; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Cetina Lucely, MSc

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. MSc.

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 18, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

ME (1)