ISRCTN90476883已完成不适用

Oral bioavailability of docetaxel in combination with cyclosporin A and activity of the combination in advance breast cancer: A randomised controlled trial

The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) (Netherlands)0 个研究点目标入组 25 人开始时间: 2010年11月10日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•Patients must have:
•1. Advanced breast cancer, measurable disease according to WHO criteria
•2. Treatment with one anthracycline containing regimen, prior adjuvant chemotherapy is allowed
•3. > 18 years
•4. Life expectancy >3 months
•5. No radiotherapy for at least 4 weeks prior to entry on study
•6. WBC > 3.0x10^9/l, platelets > 100x10^9/l
•7. WHO performance status 0-2
•8. Written informed consent
•9. Previous hormonal therapy, immunotherapy, or local radiotherapy (without compromising the indicator lesions is allowed)
•10. No history of other neoplasm, except curatively treated nonmelanoma skin cancer and curatively treated carcinoma in situ of the cervix

•1. Concomitant use of MDR converting drugs, such as Ca+ - entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol
•2. Uncontrolled infectious disease
•3. Unresolved (> grade 1) toxicities of previous chemotherapy
•4. Impaired renal function (serum creatinine > 160:mol/l, or clearance < 50ml/min)
•5. Serum bilirubin > 20:mol/l
•6. Serum albumin < 25g/l
•7. Bowel obstruction or motility disorders that may influence the reabsorption of drugs
•8. Use of H2-receptors antagonist or proton pump inhibitors
•9. Childbearing or no adequate contraception
•10. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
•11. Symptomatic cerebral or leptomeningeal metastases
•12. Unable to give written informed consent
•13. Unwilling or unable to undergo blood sampling for pharmacokinetics
•14. No prior taxane therapy

发起方

The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) (Netherlands)