NL-OMON45105已完成不适用
Phase I study evaluating indomethacin in combination with platinum-based chemotherapy - PIFA-01
niversitair Medisch Centrum Utrecht0 个研究点目标入组 18 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
- 18
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
- •- Subjects with a histological proven malignancy receiving cisplatinum combined with gemcitabine or 5FU/capecitabin (dose range cisplatin 60-80 mg/m2) (Arm I) or CAPOX (oxaliplatin, capecitabine) (Arm II) in a 21 day cycle.
- •- Platinum*based chemotherapy naïve for at least 6 months.
- •- Age * 18 years.
- •- Subjects with at least one evaluable lesion.
- •- WHO Performance Status of 0 or 1.
- •- Female participants should be of non-child bearing potential either physiologic or by using adequate contraception, have a negative serum pregnancy test, and refrain from breast feeding.
- •- Written informed consent.
排除标准
- •- Known or suspected allergy or hypersensitivity to indomethacin or any agent given in association with this trial, in particular subjects who have a history of severe hypersensitivity reactions to anti-emetics (5-HT3 antagonists, metoclopramide or corticosteroids) and acetylsalicylic acid or other prostaglandin synthethase inhibitors.
- •- Symptomatic brain or meningeal tumors
- •- Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics).
- •- Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
- •- Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
- •- Unstable angina pectoris
- •- Symptomatic congestive heart failure NYHA class * 3 (see appendix 13.6)
- •- Myocardial infarction * 6 months prior to randomization
- •- Serious uncontrolled cardiac arrhythmia
- •- Active peptic ulcer disease, gastritis, inflammatory bowel disease.
- •- History of active gastro-intestinal bleeding
- •- History of cerebro-vascular disease
- •- Bleeding diathesis
- •- Chronic renal disease defined as GFR (MDRD) < 60 ml/min
- •- Absolute Neutrophil Count (ANC) < 1.5 x 109/L (< 1500/mm3)
- •- Platelets (PLT) < 100 x 109/L (* 100,000/mm3)
- •- Hemoglobin (Hgb) < 6.0 mmol/l (patients may be transfused to achieve adequate Hb)
- •- Partial thromboplastin time (PTT) > 1,5 x ULN
- •- Serum bilirubin > 1.5 ULN
- •- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) > 3.0 x ULN (> 5 x ULN if liver metastases present)
- •- Patients who are unable or unwilling to comply with the protocol
- •- Chronic treatment with a corticosteroid agent (nebulized corticosteroids are allowed)
- •- Patients who received radiation therapy within 4 weeks of the start of the study
- •- Patients who received an experimental agent less than 4 weeks before start of the study.
- •- Patients who used Omega-3/omega-6 containing products, including fish oil products less than 2 weeks before start of the study.
- •- Chronic use of NSAID*s and/or acetylsalicylic acid and/or other prostaglandin synthethase inhibitors.
- •- Use of anticoagulant therapy
研究者
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