NL-OMON44720招募中不适用
Development and clinical activity of low dose metronomic chemotherapy with oral paclitaxel - N10MOP
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with histological or cytological proof of cancer who might benefit from treatment with paclitaxel
- •- Patients for whom no standard therapy of proven benefit exist;- Age =/> 18 years;- Able and willing to give written informed consent;- Able and willing to undergo blood sampling for pharmacokinetics and pharmacodynamics;- Life expectancy =/> 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;- Minimal acceptable safety laboratory values;a. ANC of =/> 1.5 x 109 /L;b. Platelet count of =/> 100 x 109 /L;c. Hepatic function as defined by serum bilirubin </= 1.5 x ULN, ALAT and ASAT </= 2.5 x ULN;d. Renal function as defined by serum creatinine </= 1.5 x ULN or creatinine clearance =/> 50 ml/min (by;Cockcroft-Gault formula).;- WHO performance status of </= 2;- No radio- or chemotherapy within the last 4 weeks prior to study entry ;- Able and willing to swallow oral medication;for expansion phase: able and willing to consume a high-fat meal
排除标准
- •1. Patients with known alcoholism, drug addiction, psychotic disorders in the history and/or other reasons, for which they are not amenable for adequate follow up.;2. Women who are pregnant or breast feeding. ;3. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms). ;4. Concomitant use of MDR and CYP3A modulating drugs such as Ca+ entry blockers (verapamil, dihydropyridines), cyclosporine, (non) nucleoside analoga, St. Johns worth, macrolide antibiotics as erythromycin and clarithromycin, quinidine, quinine, tamoxifen, megestrol, grapefruit juice, concomitant use of HIV medications or other protease inhibitors. ;5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients;6. Unresolved (>grade 1) toxicities of previous chemotherapy, excluding alopecia;7. Known allergic reaction against contrast agents;8. Bowel obstructions or motility disorders that may influence the absorption of drugs;9. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity;10. Pre-existing neuropathy greater than CTC grade 1;11. Symptomatic cerebral or leptomeningeal metastases;12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
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