NCT00587431已完成2 期
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
研究概览
简要总结
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
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
- •Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
- •Patient must have a serum testosterone > 180 ng/dl.
- •Karnofsky performance status (KPS)>_70%.
- •Patients must have adequate organ function as defined by the following
- •laboratory criteria:
- •WBC >_ 3500/mm3
- •ANC >_1500/mm3
- •Platelet count >100,000/mm3
- •Hemoglobin >8.0g/dL
- •Creatinine <1.6mg/dl
- •Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
- •SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in
- •AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos
- •Prior hormonal therapy is allowed as:
- •Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).
- •One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).
- •Patients must be at least 18 years of age.
- •Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
排除标准
- •Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- •Uncontrolled serious active infection.
- •Anticipated survival of less than 3 months.
- •Active CNS or epiduraltumor
- •Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
- •Peripheral neuropathy >_ grade
- •Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate
- •Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
- •Prior chemotherapy
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
研究组 & 干预措施
1
Experimental
干预措施: GnRh (Leuprolide) (Drug)
1
Experimental
干预措施: Testosterone Gel (Drug)
1
Experimental
干预措施: Docetaxel (Drug)
2
Active Comparator
干预措施: GnRh (Leuprolide) (Drug)
2
Active Comparator
干预措施: Testosterone Gel (Drug)
结局指标
主要结局
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
时间窗: Conclusion of the study (at 6 months then at 18 months post-treatment)
次要结局
- The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.(at Cycle 1 and 2)
研究者
研究点 (1)
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