Randomized, Controlled Biomarker Study Evaluating the Anti-angiogenic Activity of Sunitinib in Hormone Refractory Prostate Cancer Patients Treated by Docetaxel
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
研究概览
简要总结
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients
详细描述
Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.
We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 of 0-
- •Histologically proven prostate adenocarcinoma.
- •All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
- •Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:
- •25% increase in bidimensionally measurable soft tissue metastases
- •Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)
- •PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
- •If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization
排除标准
- •prior chemotherapy for prostate cancer
研究组 & 干预措施
Docetaxel + Sunitinib
docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles
干预措施: Docetaxel * Sunitinib (Drug)
Taxotere
docetaxel 75mg/m2 day1 q 21d x 4 cycles
干预措施: Docetaxel (Drug)
结局指标
主要结局
Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy
时间窗: 12 weeks
次要结局
- Response rate and length of treatment holidays relative to docetaxel monotherapy(6 months)