ISRCTN72088851已完成不适用
Influence of medicinal cannabis (bedrocan) on the pharmacokinetics of irinotecan and docetaxel in cancer patients
Erasmus Medical Centre (The Netherlands)0 个研究点目标入组 24 人开始时间: 2006年12月28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
- 24
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
入选标准
- •1. Histological or cytological confirmed diagnosis of any form of (metastatic) cancer:
- •a. which is refractory to conventional treatment; or
- •b. for which no other (effective) treatment options are available
- •2. Age 18 years and older
- •3. World Health Organisation (WHO) performance grade two or less
- •4. Adequate hematological functions (absolute neutrophil count more than 2.0 x 10^9/L, platelets more than 100 x 10^9/L)
- •5. Adequate renal and hepatic functions: bilirubin less than 1.25 x Upper Limit of Normal (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) less than 2.5 x ULN, in case of liver metastasis less than 5 x ULN; serum creatinine less than 1.25 x ULN; Alkaline Phosphatase (AP) 5 x ULN; patients with SGPT and/or SGOT more than 1.5 x ULN associated with AP more than 2.5 x ULN are not eligible for the docetaxel arm
- •6. Written informed consent
- •7. Complete initial work-up within two weeks prior to chemotherapy
- •8. Willingness to abstain from grapefruit, grapefruit juice, herbal dietary supplements, and herbal tea during the study period (starting three weeks before the first course)
- •9. Willingness to abstain from alcohol, car-driving, use of dangerous instruments and machinery or engagement in hazardous activity during the time of medicinal cannabis-use because of (non-excludable) interference with logical thinking, ability to concentrate, and response speed
排除标准
- •1. Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required
- •2. Symptomatic Central Nervous System (CNS) metastases
- •3. Other serious illness or medical unstable condition requiring treatment or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
- •4. Time between last anti-tumor chemotherapy treatment and first day of irinotecan or docetaxel therapy less than four weeks, provided that the patient has recovered from all relevant toxic effects
- •5. Radiotherapy within the last four weeks before chemotherapy, unless less than 20% of the bone marrow area is involved
- •6. Major surgery within four weeks before study entry (to be determined by a Medical Doctor)
- •7. History of alcohol or drug abuse, including current substance dependence, methadone maintenance
- •8. Use of St John's wort and/or other herbal medicines within four weeks before study entry
- •9. Current cannabis use and/or history of marijuana/cannabis abuse
- •10. (Chronic) use of CYP3A inhibiting medication, dietary supplements or other inhibiting compounds
- •11. (Chronic) use of CYP3A inducing medication, dietary supplements or other inducing compounds
- •12. Unwillingness to change medication, or no adequate alternatives available, when drugs known to interact with CYP3A isozymes, are taken
- •13. History of serious depression, schizophrenia, or psychosis
- •Additionally for irinotecan patients:
- •1. Unresolved bowel obstruction or chronic colic disease
- •2. Radiotherapy at abdomen
研究者
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