NCT01012141已完成2 期
Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer
Centre Jean Perrin4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Response rate as assessed by clinical, biological and paraclinical examination
研究概览
简要总结
RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.
详细描述
The purpose of this study is to assess the pathological response rate in metastatic prostate cancer patients treated by : Docetaxel with a phytochemical
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •WHO performance status 0-2
- •Life expectancy ≥ 3 months
- •Patients receiving androgen-suppressive therapy in the form of chirurgical castration by orchiectomy or pulpectomy,or medical by LHRH agonist or antagonist with or without anti-androgen or all treatment blocking non gonadic testosterone fraction
- •Resulting to testosteronemia <0,5 ng/ml
- •Histologically confirmed adenocarcinomia of prostate cancer and documented hormone independant metastatic disease - defined by: objective progression with at least one measurable lesion and/or evaluable lesion according to RECIST criteria and /or a rise in PSA level ("rising PSA")
- •Total bilirubin ≤ upper limit of normal (ULN).
- •AST and ALT ≤ 1.5 times ULN. Alkaline phosphatase ≤ 2.5 times ULN.
- •Serum creatinine < 140 µmol/L or creatinine clearance > 60 mL/ min.
- •Neutrophil count > 2.109 L-
- •Platelet count ≥ 100,000/mm
- •Hemoglobin ≥ 10 g/dL
- •Not previous chemotherapy, except Estracyt
- •No liver, kidney or heart failure link to treatment
- •No malabsorption syndrome or disease significantly affecting gastrointestinal function
- •Prior radiotherapies are permetted withing four weeks of the first study treatment and must be < 25 % of the bone marrow, and all adverse events must be resolved
- •Prior surgery are permitted.
排除标准
- •Age < 18
- •History of psychiatric disorders including psychotic disorder, dementia or seizures that would prohibit the understanding, observance and giving of informed consent
- •Previous or concomitant other malignancies except basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy
- •Patients should not have symptomatic brain metastasis
- •Concurrent severe and/or uncontrolled co-morbid medical condition
- •Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade > 2 dysphagia
- •Patients with uncontrolled infection
- •History of significant neurologic (i.e. peripheral neuropathy grade > 2 using NCI-CTC criteria v3.0)
- •Patients should not have received NSAIDs or COX2 inhibitors within the three weeks prior to starting the study
- •Treatment with any investigational drug within 30 days prior to registration
- •Patients should not have current regimen containing dietary phytonutrients
结局指标
主要结局
Response rate as assessed by clinical, biological and paraclinical examination
次要结局
- Safety as assessed by NCI CTCAE v3.0
- To assess the best neuroendocine markers between chromogranin A (CgA), neuron-specific enolase (NSE) and serotonin
- Time to progression as assessed by RECIST criteria and PSA level
- To assess compliance of per os phytonutrient treatment
- Geriatric assessment impact on compliance
研究者
Philippe Chollet
Pr
Centre Jean Perrin
研究点 (4)
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