KCT0003546已完成未知
An Open Label Phase II Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 o Limit（—）
- 性别
- Male
入选标准
- •For inclusion of a subject in the study, all of the following inclusion criteria must be fulfilled:
- •1.Subject is a male at least 20 years of age.
- •2.Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
- •3.Subject has radiologic and clinical evidence of metastatic disease initially or after treatment for localized disease. They must have metastatic or progressive disease for which there is no further curative treatment available.
- •4.Subject has an ECOG performance status of 0 to 1.
- •5.Subject has a life expectancy of 3 months or more.
- •6.At least 4 weeks since the last surgical procedures or radiotherapy prior to enrolment. Subjects must have recovered to 7.Acceptable hematologic status (without growth factor support or transfusion dependency):
- •a.ANC ? 1500 cells/µL.
- •b.Platelet count ? 100,000/µL.
- •c.Hemoglobin ? 9.0 g/dL.
- •8.Acceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance = 60 mL/min using the Cockcroft-Gault or MDRD formulas.
- •9.Acceptable liver function:
- •a.Bilirubin ? 1.5 times upper limit of normal (x ULN); does not apply to subjects with Gilbert’s syndrome diagnosed as per institutional guidelines.
- •b.AST (SGOT) and ALT (SGPT) ? 3 x ULN; if liver metastases are present, then ? 5 x ULN is allowed.
- •10.Subject must agree to use an adequate method of contraception (condom) if he is having sex with a woman of childbearing potential or with a woman who is pregnant.
- •11.Written and voluntary informed consent understood, signed and dated.
排除标准
- •For inclusion of a subject in the study, any of the following inclusion criteria must not be fulfilled:
- •1.Ongoing treatment with an anticancer agent not contemplated in this protocol
- •2.Pathologic finding consistent with neuroendocrine or small cell carcinoma
- •3.Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- •4.Non-tolerable >Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
- •5.Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop brain metastasis during the study may have their treatment interrupted to receive a course of cranial radiation and restart trial medication after a recovery period of at least 1 week. High dose corticosteroids may be employed for the management of cranial radiation but must be tapered off before resuming treatment.
- •6.Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
- •7.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •8.Subjects who have exhibited allergic reactions to taxanes.
- •9.Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- •10.The subject has legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
- •11) All corticosteroids are forbidden
- •12) Those who showed hypersensitivity to acetic acid goserelin and LHRH-like drugs
- •13) Those diagnosed with hormone-independent prostate cancer
- •14) Those diagnosed with pituitary adenoma
- •15) After receiving both testicular resections, those who can no longer expect reduction of testosterone by this drug
研究者
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