Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant - CURTAXE

Centre Jean Perrin0 个研究点目标入组 100 人开始时间: 2013年8月20日最近更新: 2018年5月7日

适应症

试验速览

暂无简介。

•- Patient older than 18 years.
•- Performance status = 2 according to the WHO criteria.
•- Life expectancy> 3 months.
•- Patient in hormonal blockade based on surgical castration by orchiectomy or pulpectomy, medical or agonist or antagonists of LHRH associated or not with anti-androgens or any other treatment that blocks the fraction of non-gonadal testosterone, resulting in a testosterone <0.5 ng / mL.
•- Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by:
•o objective progression of at least one measurable tumor target and / or assessable by RECIST,
•o and / or increase in PSA (rising PSA).
•- Satisfactory biological functions (renal, hepatic and hematologic)
•- Patient who signed the consent for participation before entering the study.
•- Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the law of 9 August 2004.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•- Age <18 years.
•- Performance status> 2 according to the WHO criteria.
•- Patient deprived of liberty or under guardianship, patient with (the) condition (s) psychological, family, social or geographic may interfere with the proper conduct of the study.
•- Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer considered cured.
•- Patient with brain metastases at initial assessment.
•- Patient with another pathology deemed incompatible with the inclusion in the protocol.
•- Laboratory tests inadequate.
•- History of malabsorption syndrome or extensive resection of the upper digestive tract.
•- Uncontrolled intercurrent infection.
•- Pathology autoimmune and / or chronic active inflammation.
•- ? peripheral neuropathy grade 2 according to the criteria of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
•- History of allergy to polysorbate 80.
•- Treatment with nonsteroidal anti-inflammatory and / or cyclooxygenase-2 dated within three weeks.
•- Concomitant with a drug test or participation in another clinical trial within <30 days treatment.
•- Regular Taking dietary supplements.

发起方

Centre Jean Perrin