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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02446652
Recruitment Status : Unknown
Verified May 2015 by Dr. Lucely Cetina Pérez, National Institute of Cancerología.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2015
Last Update Posted : May 18, 2015
Psicofarma S.A. de C.V.
Information provided by (Responsible Party):
Dr. Lucely Cetina Pérez, National Institute of Cancerología

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Hydralazine/Magnesium Drug: Placebo Drug: Carboplatin Drug: Paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial: "Evaluation of the Combination of TRANSKRIP ® Plus Carboplatin and Paclitaxel as First Line Chemotherapy on Survival of Patients With Recurrent - Persistent Cervical Cancer
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Hydralazine/Magnesium valproate + QT
This group will receive TRANSKRIP® (Hydralazine/Magnesium valproate) + Carboplatin plus Paclitaxel
Drug: Hydralazine/Magnesium
(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
Other Name: TRANSKRIP ®

Drug: Carboplatin
5 AUC 1 hour/day 1 for every 21 days for 6 cycles
Other Name: CBP

Drug: Paclitaxel
175mg/m2/SC 3hour/day 1 for every 21 days for 6 cycles.
Other Name: PXL

Placebo Comparator: placebo + QT
This group will receive placebo + Carboplatin plus Paclitaxel
Drug: Placebo
Placebo (orally) starting 1 week before the first day of the QT

Drug: Carboplatin
5 AUC 1 hour/day 1 for every 21 days for 6 cycles
Other Name: CBP

Drug: Paclitaxel
175mg/m2/SC 3hour/day 1 for every 21 days for 6 cycles.
Other Name: PXL

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    patient´s survival since inclusion in the study until final event of death.

Secondary Outcome Measures :
  1. Objective Response [ Time Frame: 6 months ]
    The treatment response will be evaluated according to the new international criteria from response evaluation committee in solid tumors (RECIST) (EJC 2009; 45:228-247). Objective Response will be evaluated after cycles 3 and 6 and every 3 months the first 2 years, every 4 months the third year, every 6 months the fourth year and later annually or until progression.

  2. Toxicity [ Time Frame: 7 months ]
    Toxicity will be evaluated every 3 weeks during QT and every 3 months at Follow up according Common Terminology Criteria for Adverse Events (CTCAE) V.3.0 spanish.

  3. Quality of life [ Time Frame: 24 months ]
    Quality of life will be evaluated according the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 and QLQ-Cx24. Quality of life will be evaluated after cycles 3 and 6 of chemotherapy and every 6 months at follow up.

  4. Progression free survival [ Time Frame: 24 months ]
    Time after treatment in wich disease remains unprogressive. Progression free survival will be evaluated through objective response after cycles 3 and 6 and every 3 months every 3 months the first 2 years, every 4 months the third year, every 6 months the fourth year and later annually or until progression.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • The recently or previously diagnosed hypertension and controlled with any antihypertensive or a combination of them (provided that they do not include hydralazine) WON'T be an exclusion criteria.

Criteria Treatment Interruption

  • A patient will be discontinued from the study under the following circumstances.
  • If there is evidence of disease progression.
  • Unacceptable toxicity.
  • If the clinician considers that a change of therapy will be for the best interest of the patient.
  • If the patient requests the discontinuation.
  • If a patient gets pregnant or does not use an adequate birth control (for patients able to conceive).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02446652

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Contact: Cetina Lucely, MSc 01 55 56280400 ext 56101

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National Institute of Cancerology
Mexico City, DF, Mexico, 14080
Contact: Lucely Cetina, MD, MSc    +52 555 628 0400 ext 56101   
Sponsors and Collaborators
National Institute of Cancerología
Psicofarma S.A. de C.V.
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Principal Investigator: Cetina Lucely, MSc Instituto Nacional de Cancerología
Dueñas-Gonzalez A, Hinojosa García LM. Papel de la quimioterapia en el carcinoma cervicouterino. Rev Inst Nac Cancerol 46: 47-57, 2000.
Lewis MJ. Análisis de la situación del cáncer cervicouterino en América Latina y el Caribe. Washington, D.C. Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS/OMS); 2004:40.

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Responsible Party: Dr. Lucely Cetina Pérez, MD. MSc., National Institute of Cancerología Identifier: NCT02446652    
Other Study ID Numbers: (014/037/ICI)(CEI/941/14)
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015
Keywords provided by Dr. Lucely Cetina Pérez, National Institute of Cancerología:
Advanced cervical cancer
Epigenetic therapy
Randomized phase III
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Vasodilator Agents