EUCTR2006-000137-35-LT进行中（未招募）不适用
Prospective controlled clinical trial of metastatic breast cancer treatment with capecitabine/docetaxel in combination with beta epoetin as compared with sole capecitabine/docetaxel treatment
AB Roche Lietuva0 个研究点目标入组 60 人开始时间: 2006年2月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- Female
入选标准
- •1. Form of informed individual consent signed prior to applying any specific trial selection procedure
- •2. Patients willing and capable to follow the requirements indicated in the protocol
- •3. Patients older than 18 years
- •4. Histologically confirmed metastatic breast carcinoma
- •5. Patients having no contraindications against capecitabine/docetaxsel treatment
- •6. Hb = 110g/l
- •7. Grade according to ECOG Performance Status: 0-2
- •8. Estimated term of life = 6 months
- •9. Agreement of pre-menopausal patients to use contraceptives during the trial terms
- •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
- •1. Other malignant tumours during the last 5 years (other than completely treated basal cells and (or) squamous cell skin carcinoma (or) squamous cell skin carcinoma and (or) cervical in situ carcinoma)
- •2. Pregnancy (positive serum pregnancy test) and breast feeding
- •3. Earlier or detected during inspection disease of CNS (e.g., primary brain tumour, seizures not controllable by standard drug medication, any brain metastases)
- •4. Clinically significant heart disease, not controllable by drug medication:
- •4.1. Heart insufficiency, symptomatic coronary heart disease or heart arrhythmia (NYHA class 3 or 4, see. Appendix III)
- •4.2. Myocardial infarction during the last 12 months
- •4.3. Treatment resistant hypertension
- •5. Peripheral neuropathy = 1 grade
- •6. Transfusion of erythrocyte mass during the last month prior to involvement into clinical trial
- •7. Anaemia not related directly to chemotherapy and (or) tumour itself
- •7.1. Iron deficiency anaemia (Fe < LLN or feritine <10 µg/l), which can not be corrected with iron supplements
- •7.2. Vitamin B12 deficiency anaemia (MCV >105 fL and/or vitamin B12 concentration < LLN), which can not be corrected with vitamin B12
- •7.3. Folic acid deficiency anaemia (MCV >105 fL and/or folic acid concentration < LLN), which can not be corrected with folic acid preparations
- •7.4. Haemolytic anaemia (laboratory indications of haemolysis: reticulocytes > ULN and indirect bilirubine >ULN ± LDH > ULN)
- •8. Any laboratory indication value as given below:
- •8.1. General blood test: number of neutrophils < 1,5 x 109/l, number of thrombocites < 50 x 109/l,
- •8.2. Biochemical blood test: total bilirubine > 1,5 x upper norm limit (ULN), ASAT, ALT > 2,5 x ULN, alkaline phosphatase > 2,5 x ULN, serum creatinine > 1,5 x ULN or creatinine clearance = 50 ml/min (calculated according to Cockroft and Gault formula or formula presented in the internet web page: http://www.globalrph.com/crcl.htm)
- •9. Present or recent (28 days prior to randomisation) uptake of another trial drug or participation in another clinical trial
- •10. Thrombophylia detected by anamnesis and/or clinically confirmed deep venous thrombosis
- •11. Acute or chronic bleeding requiring treatment during the last month
研究者
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