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

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cancerología
• Collaborator: Psicofarma S.A. de C.V.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Hydralazine; Paclitaxel; Valproic Acid

Criteria

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).