NL-OMON39193已完成不适用
Weekly administration of (bi-)daily Oral Docetaxel in combination with Ritonavir - N10BOM
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 48 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
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site. ;4. Age =/> 18 years;5. Able and willing to give written informed consent;6. Able and willing to undergo blood sampling for pharmacokinetics;7. Life expectancy =/> 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;8. 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).;9. WHO performance status of </= 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
排除标准
- •1. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable 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, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analoga, St. Johns wort or macrolide antibiotics as erythromycin and clarithromycin. ;5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients;6. Unresolved (>grade 1) toxicities of previous chemotherapy excluding alopecia;7. 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.
研究者
相似试验
招募中
不适用
Weekly administration of Oral Docetaxel in combination with Ritonaviradvanced cancer10027656NL-OMON39153Antoni van Leeuwenhoek Ziekenhuis100
已完成
不适用
Weekly administration of oral docetaxel in combination with ritonavir for the treatment of a variety of tumour typesCancerISRCTN32770468The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/ALH) (Netherlands)78
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 - METRONOMIChormone refractory prostate carcinomaMedDRA version: 6.1Level: HLTClassification code 10036908EUCTR2006-003585-34-IT40
已完成
1 期
Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With RitonavirCancerNCT01173913The Netherlands Cancer Institute57
进行中（未招募）
不适用
Continuous vs intermittent weekly docetaxel in the elderly patient with advanced and hormone-refractory prostate cancer: a randomized phase II study - NDAdvanced and hormone-refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastaticEUCTR2008-001632-13-ITEGA ITALIANA PER LA LOTTA CONTRO I TUMORI