Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

Exclusion Criteria

• •1. De novo metastatic patients who needs immediate docetaxel therapy;
• •2. Within 4 weeks prior to randomisation, the patient has received other study medication or failed to recover from any adverse events caused from a previously administered study drug
• •3. ≥ Grade 2 anticancer therapy-related toxicity (except alopecia),
• •4. Has had radiotherapy or immunotherapy within 4 weeks prior to treatment,
• •5. Has had a surgery within 4 weeks prior to treatment,
• •6. Known or suspected brain metastasis (stable patients with locally treated, asymptomatic brain metastases are not excluded),
• •7. Inadequate laboratory function:
• •1. Absolute neutrophil count \<1.5 x 109 /L (1,500 per mm3),
• •2. Platelet count \< 100 x 109 /L (100 000 per mm3),
• •3. Hemoglobin ≤9.0 g/dL,
• •4. Serum bilirubin \> ULN,
• •5. AST or ALT
• •i.\>2.5 x ULN in patient without liver metastases, ii.\>5x ULN in patients with liver metastases.
• •8. Cardiological status:
• •1. Uncontrolled hypertension (BP ≥ 150/95 with hypertension treatment)
• •2. Heart failure (NYHA III or higher),
• •3. Current or former diagnosis of cardiomyopathy,
• •4. LVEF ≤ 50%,
• •5. Atrial fibrillation with \>100bpm pulse,
• •6. Unstable ischemic heart disease (myocardial infarction within 6 months or angina that require more than one nitrate therapy each week).
• •9. Other uncontrolled or severe systemic disease, active infection, hepatitis B, hepatitis C, HIV,
• •10. Uncontrolled seizure disorder,
• •11. Active gastric and duodenal ulcers,
• •12. Recurrent nausea and vomiting, chronic gastrointestinal disease or intestinal resection that prevents proper absorption,
• •13. Severe psychiatric illness (including but not limited to manic psychiatric disorder, schizophrenia, bipolar disorder, major depression requiring hospitalization) or social disturbance that limits eligibility for examination,
• •14. History of other malignancy within the last 5 years (except properly treated basalioma or squamous cell carcinoma of the skin and in situ carcinoma),
• •15. History of allergic reaction to phenelzine, selegiline or other monoamine oxidase inhibitors (MAOIs) biological agents or similar chemical ingredients,
• •16. History of allergic reaction to docetaxel therapy or its ingredients,
• •17. Significant peripheral neuropathy (≥ Grade 2),
• •18. Selegiline is contra-indicated for concomitant use with:
• •1. Certain narcotic analgesics (eg. pethidine),
• •2. Drugs that enhance the sympathetic nervous system,
• •3. Other MAO inhibitors,
• •4. Drugs similar to MAO inhibitors,
• •5. Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs),
• •6. Tricyclic antidepressants.