EUCTR2006-003585-34-IT进行中（未招募）不适用
WEEKLY DOCETAXEL COMBINED WITH DAILY ORAL LOW DOSES OF PREDNISONE AND CYCLOPHOSPHAMIDE IN HORMONE-REFRACTORY PROSTATE CARCINOMA A PHASE I/II STUDY - METRONOMIC
未提供0 个研究点目标入组 40 人开始时间: 2006年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Histologically confirmed prostate adenocarcinoma foci of neuroendocrine differentiation are permitted Metastatic disease with documented clinical progression CT or bone scan, MRI and/or biochemical progression PSA increase refractory to hormone therapy. For those patients whose the sole evidence of progressione is the PSA raise, a minimum value of 20 ng/ml of PSA is requested for accrual Measurable disease one-dimension and/or non-measurable e.g. new lesions on bone scan . In case of sole clinical progression, patients must have at least one measurable lesione according to RECIST criteria Patients must have received a previous hormonal therapy defined as follows surgical castration or medical castration LHRH agonists with or without anti-androgens if the patient has been treated with LHRH analogues, these must be continued Evaluation of anti-androgen withdrawal syndrome if the patients has been treated with anti-androgens, these must have been withdrawn since 4 weeks, in case of flutamide or cyproterone acetate, or 6 weeks in case of bicalutamide; patients must show further progression, though the antiandrogen withdrawal, before entering the study Suppressed levels of testosterone T 8804; 50 ng/dl . Previous oral estramustine is permitted; however, this drug must have been withdrawn from at least 4 weeks, with complete recovery from its side-effects Previous radiotherapy is permitted, if completed from at least 4 weeks and covering 25 of bone marrow, with with complete recovery from its side-effects Previous surgery is permitted, even with palliative intent, if performed from at least 4 Life expectancy 3 months Age 18 and 80 years PS 8804; 2 ECOG Scale Neutrophils 8805; 1.500/L; Platelets 8805; 100.000/L; Hemoglobin 8805; 9 g/dl AST e ALT 8804;2.5 times upper normal limit; Bilirubin 8804;1.5 times upper normal limit; Creatinine 8804;1.5 times upper normal limit for creatinine values between 1.4 e 1.5 times, creatinine clearance will be calculated, and the clearance will have to be 8805;50ml/min Accessibility to therapy and follow up for patients 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
- •Central nervous system metastases Other tumors, except skin basalioma unless the patient is free of disease from 8805;5 years Severe respiratory or cardiovascular diseases congestive heart failure, positive history for acure myocardial infarction, angina pectoris, in the 6 moths preceding the study enter; non-controlled arrhythmias or hypertension Non-controlled diabetes mellitus , peptic ulcer, other contraindications to the use of corticosteroids Active infections Severe peripheral neuropathy 8805; grade 2 NCI-CTC . Severe neurological or psychiatric impairments Previous chemotherapy except estramustine, if withdrawn from at least 4 weeks before entering the study Concomitant treatment with other antineplastic drugs except LHRH analogue Accrual in other clinical trials with other experimental drugs in the 30 days preceding the inclusion in the study, or concomitant therapy with other experimental drugs Previous therapy with radioisotopes e.g strontium or samarium ; Systemic corticosteroid therapy for reason different from those specified in the protocol Hypersensitivity to Polysorbate 80
研究者
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