hormone refractory metastatic prostate cancer
Conditions
Interventions
Trade Name: Everiden
Pharmaceutical Form: Tablet
Sponsors
National Cancer Institute
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. signed written informed consent 2. men aged 18 years or older 3. histologically proven metastatic hormone refractory prostatic adenocarcinoma, with progression after standard 1st line chemotherapy (only docetaxel+prednisone). The progression is defined: progression according RECIST criteria or evidence of PSA progression. Minimum evidence of progression is a 25% increase over a reference value of PSA (20ng/mL), provided that the increase is > 5 ng/mL. The first increase in PSA should occur at a minimum of one week from the reference value. This increase should then be confirmed by a second increase in PSA at least 1 week later (Bubley, 1999). 4. patients with measurable or non-measurable disease as defined in the RECIST criteria: At least one site of disease must be unidimensionally measurable as follows: X-ray, physical exam > 20 mm } N.B. Most hospitals have spiral CT scanning Spiral CT scan > 10 mm } equipment – check with your radiology department. Non-spiral CT scan > 20 mm } All radiology studies must be performed within 28 days prior to registration 5. ECOG PS 0 – 1 at study entry 6. at least 4 weeks must have elapsed since the last surgery, radiotherapy and/or chemotherapy before study entry 7. complete recovery from prior surgery, and/or reduction of all adverse events to grade 1 from previous systemic therapy or radiotherapy 8. no concurent treatment with experimental drugs was allowed. 9. no concurrent chemotherapy. Corticosteroids and bisphophonates are permitted if they were admistered more than 2 months before study entry in the same dose and route of application. 10. patients with surgical castration or patients without surgical castration must have a serum testosterone level less than 50ng/ml before study entry and to continue on LHRH agonist therapy 11. adequate renal function defined as creatinine clearance > 60ml/min 12. adequate liver function defined by normal total bilirubin level and ALT, AST 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl. 14. normal blood coagulation tests: INR, fibrinogen, PTT, bleeding time 15. serum albumin level > 34g/l 16. life expectancy more than 3 months 17. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. inability to absorb medication e.g. malabsorption syndrome 2. hepatic porphyria 3. acute or chronic hepatitis (positivity HbsAg, antiHCV and/or LFT`s see also inclusion criteria) 4. hypersensitivity to valproic acid 5. personal or familial history of severe drug induced hepatitis 6. grade 3-4 infection without neutropenia 7. known CNS metastasis 8. Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years. 9. Serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator ) 10. systemic lupus erythematosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as measured by tumor response) of valproic acid given orally to patients with hormone refractory metastatic prostate cancer after first line chemotherapy.;Secondary Objective: To describe the time to progression and toxic effects of valproic acid in patients with hormone refractory metastatic prostate cancer. ;Primary end point(s): Response rate (according to Bubleys criteria) | — |
Countries
Slovakia
Outcome results
None listed