NL-OMON32425尚未招募不适用
Phase I interaction study of Docetaxel with supplementation of St. John*s wort or Echinacea - Interaction study of Docetaxel and St. John*s wort or Echinacea
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 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
- 尚未招募
- 发起方
- 入组人数
- 20
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
- •1. Patients for whom treatment with docetaxel is considered to be of therapeutic benefit, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer and prostate cancer
- •2. Histological or cytological proof of malignancy
- •3. Age >=18 years
- •4. Performance: WHO <= 2
- •5. Life expectancy > 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity
- •6. Minimal acceptable safety laboratory values:
- •a) ANC of >= 1.5 × 109/L
- •b) Platelet count of >= 100 × 109/L
- •c) Haemoglobin level of >= 6.0 mmol/L
- •(prior transfusion is permitted)
- •d) Hepatic function as defined by serum bilirubin <= 1.5 times the upper limit of normal (ULN), ALT and AST <= 2.5 times the ULN
- •e) Renal function as defined by serum creatinine <= 1.5 times ULN or creatinine clearance >= 50 mL/min (by Cockcroft-Gault formula)
- •7. Able and willing to swallow and retain oral medication.
- •8. Able and willing to undergo blood sampling for pharmacokinetics
- •9. Willing to comply to the protocol and to follow dietary restrictions
- •10. Written informed consent.
排除标准
- •1. Any treatment with investigation drugs within 30 days before the start of the study
- •2. Patients with known alcoholism, drug addiction and/or a history of psychotic disorders that are not suitable for adequate follow up
- •3. Men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, contraceptive pill (female partner), abstinence from sexual intercourse, sterilisation of man or woman).
- •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 analogs, or St. Johns wort.
- •5. Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
- •6. Unresolved (>grade 1) toxicities of previous chemotherapy
- •7. Bowel obstruction or motility disorders that may influence the absorption 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. Use of herbal supplements, especially St. John*s wort or echinacea, within 6 weeks prior to study treatment.
研究者
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