NL-OMON44297已完成不适用
Clinical pharmacokinetics of intravenous docetaxel in patients with castration-resistant prostate cancer and non-castration-resistant prostate cancer - Pharmacokinetics of intravenous docetaxel
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histological or cytological metastatic prostate cancer with an indication for systemic treatment with intravenous docetaxel at the discretion of the physician
- •Planned to receive first time docetaxel for prostate cancer.
- •Group 1: Metastatic castration-resistant prostate cancer with progressive disease defined as biochemical and/or radiological progression according to the Prostate Cancer Working group 3 recommendations. (4) These patients have progressive disease despite long term treatment with hormonal therapy, so they have longterm castrate levels of testosterone. Docetaxel is started after progression on hormonal therapy.
- •Group 2: Non-castration-resistant metastatic prostate cancer with an indication for first line docetaxel according to standard clinical care. These patients have metastatic disease at diagnosis and they receive their first systemic treatment as a combined treatment with hormonal therapy and docetaxel. The hormonal therapy is started between 12 and 4 weeks prior to the start of docetaxel. Therefore these patients have castrate levels of testosterone at the start of docetaxel.
- •2. Considered fit for docetaxel treatment as assessed by the treating physician.
- •3. Castrate levels of testosterone, defined as <= 50 ng/dL (or <= 0.50 ng/mL or 1.73 nmol/L)
- •4. Age >= 18 years.
- •5. Able and willing to give written informed consent.
- •6. Able and willing to undergo blood sampling for PK and pharmacogenetics analysis.
- •7. Able and willing to comply with study restrictions and to remain at the study center for the required duration.
- •8. Adequate organ system function.
排除标准
- •not applicable
研究者
相似试验
招募中
1 期
Investigation of therapeutic efficacy of docetaxel, cisplatin and S1 (DCS) chemotherapy for advanced or recurrent gastric cancerAdvanced/Recurrent Gastric cancerJPRN-UMIN000019972Teikyo University Chiba Medical Center40
招募中
不适用
Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant in Japanese patients with solid tumors.cancerJPRN-UMIN000007629Saitama Medical University, International Medical Center30
已完成
2 期
Phase II study of intraperitoneal docetaxel combined with capecitabine plus cisplatin for advanced gastric cancer with peritoneal metastasisgastric cancer with peritoneal metastasisJPRN-UMIN000016469The University of Tokyo50
已完成
1 期
Phase I study of intraperitoneal docetaxel combined with capecitabine plus cisplatin for advanced gastric cancer with peritoneal metastasisgastric cancer with peritoneal metastasisJPRN-UMIN000012971The University of Tokyo12
已完成
不适用
Oral bioavailability of docetaxel in combination with cyclosporin A and activity of the combination in advance breast cancerCancer, advanced breast cancerMalignant neoplasm of breastCancerISRCTN90476883The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) (Netherlands)25