Phenamate in the treatment of prostate cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

MEFEPROST

Scientific title:

New therapeutic regimen for patients with hormone-resistant prostate cancer: Phase II-III clinical trial using the anti-inflammatory with the highest anti-tumor effect in pre-clinical trials (meclo/mefenamate) combined with standard treatment (Docetaxel)

Acronym of Scientific Title:

MEFEPROST

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

CONACYT-MEXICO

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ivan

Last name:

Delgado-Enciso

Medical Specialty :

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email address:

ivancoliman@hotmail.com [1]

ivan_delgado_enciso@ucol.mx [2]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Monterrey, Nuevo Leon, "Jose Eleuterio Gonzalez" Hospital of the Autonomous University of Nuevo Leon. Biomedical Researcher Iram Pablo Rodriguez Sanchez

Villa de Alvarez, Colima, Mexican Social Security Institute. Urologist Jose Guzman Esquivel

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), March 17, 2017 (Central Ethics Committee)

National Scientific Commission of Mexican Social Security Institute, (Central Ethics Committee)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

01/12/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Prostate cancer with resistance to castration.

Health condition(s) code:

Prostatic Neoplasms, Castration-Resistant

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Health condition keyword:

Prostate cancer

Intervention(s):

Docetaxel (Control Group 1): Chemotherapy (Docetaxel) 75 mg / m2 intravenously for six cycles every 3 weeks. Meclo/mefenamic acid (Experimental group 1): Chemotherapy (Docetaxel) + Meclo/mefenamic acid. Docetaxel 75 mg/m2 intravenously for six cycles every 3 weeks. Alongside Docetaxel dosage, 500mg of mefenamic acid or 200 mg of meclofenamic acid will be administered every 12 hours, orally, for 6 months. Placebo (Control Group 2): Placebo. Patients who are not suited for chemotherapy or refuse to receive it, a placebo pill will be administered every 12 hours orally for 6 months. Mefenamic acid (Experimental group 2): Mefenamic acid. Patients who are not suited for chemotherapy or refuse to receive it, 500mg mefenamic acid will be administered every 12 hours orally for 6 months.

Intervention code:

Drug Therapy

Mefenamic Acid

Administration, Intravenous

Administration, Oral

Intervention keyword:

Docetaxel

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Complete response (RECIST 1.1). Measuring time: 3 and 6 months.

Key secondary outcomes:

Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE version 3). Measurement time: Every week until month 6. Change in the level of the specific prostate antigen at 6 months of treatment. Change in the Mini-Mental State Examination (MMSE) score at 6 months of treatment. Changes in the levels of genetic expression in prostate cancer tissue at 6 months of treatment

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

40 years

Maximum age:

None

Inclusion criteria:

1. Clinical and histological diagnosis of castration-resistant prostate cancer. 2. That the treating oncologist considers that the administration of Docetaxel is the feasible and appropriate treatment for the patient (for control group 1 and experimental group 1). 3. Functional status ECOG 0 to 2. 4 Patients with no history of hepatic impairment or renal impairment (creatinine clearance should be greater than 60 milliliters / minute). 5. Sign written informed consent of the patient.

Exclusion criteria:

1. ECOG 3 or greater 2. Diagnosis of second primary cancer. 3. Patients with uncontrolled arterial hypertension 4. Creatinine clearance less than 60 milliliters per minute 5. Leukocytes less than 3000 cells / microliter or platelet count less than 100,000 cells / microliter 6. Leukocytes greater than 10,000 cells / microliter or showing data Of systemic infection 7. Blood hemoglobin less than 9gr / deciliter 8. Alcoholism and / or drug addiction 9. Gastrointestinal ulcer 10. Inflammatory bowel disease 11. Diagnosis of ischemic heart disease 12. Other pathologies at the discretion of the investigator.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Jose

Last Name:

Guzman-Esquivel

Specialty:

Urology

Affiliation:

Medical School of the University of Colima, Mexico

Postal Address:

Avenue Universidad 333, Colonia las viboras

City:

Colima

País:

Mexico

Zip Code:

28040

Telephone:

+52-3123161099

Email :

pepeguzman_esquivel@outlook.com [3]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ivan

Last Name:

Delgado-Enciso

Specialty:

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivancoliman@hotmail.com [1]

ivan_delgado_enciso@ucol.mx [2]

About study completion

Section to complete the data related to the study completion.

Study completion date:

18/11/2019

Date of available results:

01/11/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000248

Date of Registration in Primary Registry:

15/08/2017

Record Verification Date:

2017/08/15

Next update date:

2018/08/15

Link to the spanish version:

Click here [4]