ISRCTN32770468已完成不适用
Weekly administration of oral docetaxel in combination with ritonavir for the treatment of a variety of tumour types: an optimal dosing study
The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/ALH) (Netherlands)0 个研究点目标入组 78 人开始时间: 2011年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological proof of cancer
- •2. Patients for whom no standard therapy of proven benefit exist
- •3. Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, oesophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site
- •4. Aged greater than or equal to 18 years
- •5. Able and willing to give written informed consent
- •6. Able and willing to undergo blood sampling for pharmacokinetics
- •7. Life expectancy greater than or equal to 3 months allowing adequate follow up of toxicity evaluation and anti-tumour activity
- •8. Minimal acceptable safety laboratory values
- •8.1. Absolute neutrophil count (ANC) of greater than or equal to 1.5 x 10^9/L
- •8.2. Platelet count of greater than or equal to 100 x 10^9/L
- •8.3. Hepatic function as defined by serum bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN
- •8.4. Renal function as defined by serum creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than or equal to 50 ml/min (by Cockcroft-Gault formula)
- •9. World Health Organisation (WHO) performance status of less than or equal to 2
- •10. No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation for pain reduction is allowed)
- •11. Able and willing to swallow oral medication
- •12. Arm F: Patients for whom weekly paclitaxel can seriously be considered therapy with palliative intent, with tumour types that reasonably will respond
排除标准
- •1. Patients with known alcoholism, drug addiction and/or a history of psychotic disorders that are not suitable for adequate follow up
- •2. Women who are pregnant or breast feeding
- •3. Both men and women who do not agree to use a reliable contraceptive method throughout the study
- •4. Concomitant use of MDR and CYP3A modulating drugs such as Ca+ entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of human immunodeficiency virus (HIV) medications; other protease inhibitors, (non) nucleoside analoga, or St. Johns wort
- •5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
- •6. Unresolved (greater than grade 1) toxicities of previous chemotherapy
- •7. Bowel obstructions or motility disorders that may influence the resorption of drugs
- •8. Chronic use of H2-receptor antagonists or proton pump inhibitors
- •9. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
- •10. Symptomatic cerebral or leptomeningeal metastases
- •11. Acid neutralizing medicines (e.g. aluminium hydroxide), should not be administered for at least 2 hours prior to and after the intake of ketoconazol (Arm D)
研究者
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