Terapia di II linea con Docetaxel + Lanreotide in pazienti con carcinoma prostatico metastatico ormonorefrattario e in progressione in corso di chemioterapia di I linea con Docetaxel. Studio di fase II. - RESTORE

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST0 个研究点开始时间: 2010年3月1日最近更新: 2012年9月25日

适应症

试验速览

暂无简介。

•-Histologically proven prostate adenocarcinoma
•-Age years: ≥ 18
•-Estimated life expectancy of at least 3 months
•-Performance status < 2
•-Adeguate bone marrow (neutrophyles count ≥ 1,500/mm3; platelets ≥ 100,000/mm3; haemoglobin ≥ 10 g/dL), renal and liver function.
•-Evidence of metastatic hormone-refractory prostate cancer, with adeguate testoterone suppression and progressive disease under Docetaxel treatment.
•-Serological progression (i.e. two consecutive PSA determinations at minimum two weeks interval, showing a 25% increase compared to the lower level observed during chemotherapy or disease progression confirmed by CT scan or MRI.
•-Normal ranges of Cromogranina A [20 98 ng/ml].
•-Patient compliance.
•-Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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

•-Histological and/or serological (CgA) diagnosis of neuroendocrine tumor (prostatic and extra-prostatic); other concomitant neoplasms (except basal cell carcinoma).
•-Chronic PPI therapy.
•-Renal impairment.
•-Uncontrolled arterial hypertension.
•-Parkinsons disease.
•-Peripheral neuropathy grade>2 (NCI-CTC versione 3.0).
•-Uncontrolled active infections.
•-Active peptic ulcer, uncontrolled Diabetes mellitus or other controindications to the cortisonic therapy.
•-Myocardial infarction (within 12 mounths before written informed consent), uncontrolled angina or uncontrolled cardiac arrhythmia.
•-Other ongoing antitumoral treatments.
•-Concomitant enrollment in other Clinical Studies.
•-Known allergic reactions to study drugs.
•-Neurological and /or psychiatrical symptoms.
•-Any other severe clinical condition that, by Investigators evaluation, produced an unjustified risk for the patient and be interferring with the study.

发起方

G.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST