EUCTR2011-002087-24-GR进行中（未招募）1 期
A phase II study of Temsirolimus in patients with advanced hormone - and chemotherapy - resistant prostate cancer. - N/A
Hellenic Oncology Research Group (HORG)0 个研究点开始时间: 2011年6月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Histologically or cytologically confirmed prostate cancer in relapse
- •2. laboratory confirmation of hormone resistance by measuring LH, FSH, DHEA, testosterone.
- •3. continued increase of PSA despite adequate androgen blockade and administration of at least one line of chemotherapy (docetaxel, vinorelbine).
- •4. ECOG Performance Status 0-2 (see Appendix I)
- •5. Patients must be >18 and =80 years
- •6. life expectancy >=3 months
- •7. signed informed consent
- •8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •9. Patients with both measurable and non measurable disease will be allowed to enter the trial and will be followed for response as described in Section 6.1.1 of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. concomitant use of any other antineoplastic treatment with the exception of LHRH inhibitors and bisphosphonates for the treatment of bone metastases
- •2. chronic active hepatitis or cirrhosis or billirubin>1.5 the upper limit of normal (ULN)
- •3. active infection, cachexia or serious psychiatric disease
- •4. isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
- •5. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
- •6. Diagnosis of any second malignancy, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
- •7. Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
- •8. Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- •9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •10. Concurrent treatment with other experimental drugs and/or anticancer agents
- •11. Patients must be surgically sterile, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- •12. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
- •13. any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
研究者
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