NCT02095717终止2 期
Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
Centre Jean Perrin4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Time to progression
研究概览
简要总结
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. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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: objective progression of at least one measurable tumor target and / or assessable by RECIST, 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.
排除标准
- •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
- •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.
研究组 & 干预措施
Curcumin
Experimental
curcumine capsule
干预措施: Curcumin (Drug)
Curcumin
Experimental
curcumine capsule
干预措施: Taxotere (Drug)
Placebo
Placebo Comparator
placebo capsule
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
placebo capsule
干预措施: Taxotere (Drug)
结局指标
主要结局
Time to progression
时间窗: participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause
Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial). Progression was defined as an increase (of) injury (s) tumor (s) (RECIST) or an increase in PSA levels (≥ 25% and ≥ 2ng/ml increase) or the appearance of new lesions metastatic (at least 2 new lesions for bone lesions). From date of randomization until the date of first documented progression or date of death from any cause
次要结局
- PSA response(From date of randomization until the date of first documented PSA progression or date of death from any cause)
- objective tumor response rate(participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months))
- Overall survival(from date of randomization until the date of death from any cause)
- safety and tolerability(patients will be followed for the duration of the treatment, an expected average of 4 months)
- Pain(participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment))
- neuroendocrine markers(participants will be followed for the duration of the treatment, an expected average of 4 months)
- anti-angiogenic activity(participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months)
- compliance(patients will be followed for the duration of the treatment, an expected average of 4 months)
研究者
研究点 (4)
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