PER-034-00已完成未知
Phase II Evaluation of the Efficacy and Safety of Intravenous Estramustine Phosphate in Patients with Measurable Metastatic Cancer of Hormone Refractory Prostate.
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2000年6月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •Adult Men with a histopathologically proven diagnosis of prostate cancer.
- •Measurable disease, bidimentionally at least 1cm x 1cm.
- •Patients who have progressed in hormone therapy, ex. either they have an increase in the size of a new measurable lesion, a new lesion in a bone scan or a> 50% increase in AEP for a minimum of 5 ng / mL. Patients on LEIRH therapy should continue with it.
- •Patients should have castrate testosterone levels (<1,735 mmoL / L or <50 ng / dL).
- •Acute toxic effects (excluding alopecia) due to previous therapies should be classified as grade <1 in the Common Toxicity Criteria, National Cancer Institute.
- •A central venous catheter must be applied before starting the therapy under study.
- •Patients must be> 18 years of age.
- •Patients must have an ECOG performance status of O, 1, or 2.
- •Patients should have an expected survival of> 3 months.
- •Patients must have a sufficient reserve of bone marrow indicated by the granulocyte count greater than or equal to 1500 / mm3, and platelets count> 100,000 / mm3
- •Patients should have adequate renal function: creatinine <1.5 mg / dL,
- •Patients should have adequate liver function with total bilirubin <1.5 mg / dL, transaminase (TSGO) <3 x the upper normal limit.
- •Each patient must be fully aware of the nature of the disease process and give their consent willingly after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks and discomfort with therapy and placement of a central venous catheter (Informed Consent).
排除标准
- •Patients who have received more than one prior chemotherapy
- •Patients who have received previous therapy with estramustine phosphate.
- •Patients who have received therapy with high doses of estrogen in the last year.
- •Patients who have received radioisotopes during the past 90 days
- •Patients with <4 weeks since treatment with flutamide, nilutamide, or <6 weeks since treatment with bicalutamide has been discontinued. If a withdrawal syndrome is observed, ex. a 50% decrease in AEP, then the patient can not be included until the AEP has risen again 50% or to> 5 ng / mL.
- •Patients with <1 week of previous surgery (excluding minimal procedures such as insertion of a vascular access device).
- •Patients with a previous history of profuse venous thrombosis and / or pulmonary embolism, coagulation disorders.
- •Patients with active angina, including stable angina or unstable angina.
- •Patients with a history of myocardial infarction, congestive heart failure, temporary ischemic attack or stroke within the last 6 months.
- •Known leptomeningeal disease (it will be CT, I RM, brain, in case of clinical suspicion of alaterations in the central nervous system).
- •Patients with concomitant infections including known HIV infection
- •Patients with other cancers except skin melanoma not treated properly.
- •Patients with other severe concurrent diseases that make the patient´s judgment inappropriate to participate in this study.
- •Patients with mental or psychiatric disability that interfere with the ability to give the consent report or complete visits.
研究者
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