A Safety and Feasibility Study of Mitotane in Prostate Cancer
Ключови думи
Резюме
Описание
All patients will undergo pre-study assessment for symptoms, performance status, ECG, CT abdomen/pelvis, Bone scan, Complete blood count tests(hematology) , Biochemistry tests like serum electrolytes, liver function tests, coagulation profile, testosterone and PSA tests.
Mitotane will be administered 1.5g daily escalation to maximum of 5 g daily then adjusted according to serum levels and tolerability
Physical examinations, hematology, biochemistry tests, and toxicity evaluations will be measured throughout patients on protocol treatment
Mitotane serum level will be analyzed every second cycle
Research bloods include; ACTH, cortisol, deoxycorticosterone, aldosterone, corticosterone, and testosterone, androstenedione, dehydroepiandrostenedione (DHEA), DHEA sulfate (DHEA-S) and estradiol will be collected only in cycle 1,3 and 5
Дати
| Последна проверка: | 10/31/2015 |
| Първо изпратено: | 01/27/2014 |
| Очаквано записване подадено: | 02/04/2014 |
| Първо публикувано: | 02/06/2014 |
| Изпратена последна актуализация: | 11/10/2015 |
| Последна актуализация публикувана: | 12/16/2015 |
| Дата на първите подадени резултати: | 11/10/2015 |
| Дата на първите подадени резултати от QC: | 11/10/2015 |
| Дата на първите публикувани резултати: | 12/16/2015 |
| Действителна начална дата на проучването: | 08/31/2013 |
| Приблизителна дата на първично завършване: | 03/31/2015 |
| Очаквана дата на завършване на проучването: | 09/30/2015 |
Състояние или заболяване
Интервенция / лечение
Drug: single arm
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: single arm Mitotane will be administered on an outpatient or inpatient basis. | Drug: single arm Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Biopsy-proven prostate cancer OR a clinical picture consistent with metastatic prostate cancer with high levels of serum PSA (>20ng/ml) - Progressed on docetaxel chemotherapy after a minimum of 3 cycles and/or stopped treatment because of toxicity. Patients may have had previous mitoxantrone, either before or after docetaxel treatment - Response to a minimum of a 50% fall in PSA maintained for 4 weeks and then progressed through abiraterone treatment - At least 2 consecutive rising PSAs measured at least 1 week apart . Patients must have ceased abiraterone at least 1 week prior. - Serum PSA > 10 ng/ml - ECOG performance status /=60%) - Normal organ and marrow function as defined: - Absolute neutrophils count ≥ 1,500/uL - platelets ≥100,000/uL - total bilirubin ≤1.5 X institutional ULN - AST(SGOT)/ALT(SGPT) ≤ 2 X institutional ULN - creatinine ≤ 1.5 X institutional ULN - Men must agree to use adequate contraception prior to study entry - Life expectancy > 3 months - CRPC documented by PSA increase despite having: a) orchidectomy OR b) continuous LHRH agonist treatment. This should be documented by a baseline serum testosterone suppression (<1.75 nmol/L) Exclusion Criteria: - Prior anticancer treatment with Mitotane - May not be receiving any other investigational or anticancer agents while on study - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, poorly controlled diabetes mellitus, clinically significant or untreated ophthalmologic (e.g. Sjogrens etc.) or gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis) or psychiatric illness/social situations that would limit compliance with study requirements - Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin - Radiotherapy within the past 4 weeks - Pre-existing pituitary or adrenal dysfunction - Patients on spironolactone as this may interfere with the action of mitotane - Patients on warfarin as mitotane may unpredictably interfere with INR measurements |
Резултат
Първични изходни мерки
1. The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events [maintain 50% of the patients on Mitotane at the 12 week mark]
Вторични изходни мерки
1. Prostate Specific Antigen (PSA) Response Rate [PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.]
