EUCTR2005-002027-13-GB进行中（未招募）1 期
A phase I/II study of docetaxel plus prednisolone plus diethylstilbestrol plus aspirin in androgen-independent prostate cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
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
入选标准
- •Histologically, cytologically or biochemically proven prostate adenocarcinoma.
- •Serum testosterone < 2 nmol/l. Ongoing androgen deprivation therapy with LHRH analogues or bilateral orchidectomy.
- •Progressive disease defined as a PSA rise using 3 serum PSA measurements, each obtained at least 7 days apart within the 3 months prior to start of trial. Patients who were withdrawn from anti-androgen therapy less than 6 weeks prior to inclusion in the study also require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir ? 4 weeks from treatment withdrawal if treated with flutamide and ? 6 weeks if treated with bicalutamide or nilutamide. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
- •Life expectancy ? 3 months.
- •ECOG performance status 0-2
- •Adequate haematological, renal and hepatic function
- •Left ventricular ejection fraction > 45%
- •Written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior cytotoxic chemotherapy, diethylstilbestrol, other oestrogen, estramustine or radioisotope therapy
- •Other malignant disease within the previous 5 years, other than adequately treated basal cell carcinoma.
- •External beam radiotherapy, brachytherapy or cryotherapy within 6 weeks of start of study.
- •Haemoglobin <10.0 g/dl, ANC <1.5 x 109, platelets <100 x 109.
- •Bilirubin >ULN, AST >1.5 x ULN, ALT > 1.5 x ULN.
- •Patients with serious or uncontrolled co-existent non-malignant diseases. Active or uncontrolled infection.
- •History of thrombo-embolic disease
- •Aspirin hypersensitivity
- •Symptomatic peripheral neuropathy ? grade 2 (NCI CTC)
- •Treatment with any investigational compound within 30 days
- •Concurrent use of CYP3A4 modulating drugs
研究者
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