Prostate cancer with resistance to castration. Prostate cancer
Conditions
Interventions
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 ac
Drug Therapy
Administration, Intravenous
Administration, Oral
Docetaxel
Sponsors
Medical School of the University of Colima, Mexico
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Mexican Social Security Institute.
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (RECIST 1.1). Measuring time: 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mexico
Contacts
Public ContactJose Guzman-Esquivel
Medical School of the University of Colima, Mexico
Outcome results
None listed