EUCTR2009-009470-27-GB进行中（未招募）1 期
PHASE II TRIAL OF THE EFFECT OF GEMCITABINE WITH INTRAVENOUS OMEGA 3 FISH OIL INFUSION IN PATIENTS WITH UNRESECTABLE PANCREATIC ADENOCARCINOMA. - FISH OIL AND GEMCITABINE IN PANCREATIC ADENOCARCINOMA - VERSION 1
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 50 人开始时间: 2009年4月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients with histologically or cytologically confirmed pancreatic adenocarcinoma, in whom the disease is assessed as unresectable, either due to metastatic or locally-advanced disease, and deemed suitable to receive gemcitabine chemotherapy will be eligible for the study. The inclusion criteria will be:
- •Aged >18 years
- •Able to give informed written consent
- •ECOG performance status of 0 or 1 (Appendix 1)
- •Life expectancy >12 weeks
- •Adequate hepatic and renal function documented within 14 days prior to treatment
- •AST and ALT =2.5x upper limit of normal (ULN), unless liver metastases present, in which case =5.0xULN
- •Total bilirubin =1.0xULN
- •Serum creatinine =1.5xULN or calculated creatinine clearance =60ml/min
- •Urinary protein <1+ by urine dipstick. If =1+, then 24-hour urine collection should be done and may only be enrolled if urine protein is <2g/24hours
- •Adequate bone marrow function
- •Haemoglobin =9g/dL (can have transfusion or growth factors)
- •Platelets =100,000cells/mm3
- •Neutrophil count =1500cells/mm3
- •No significant hyperlipidaemia
- •Patients without severe blood coagulation disorders (anticoagulants allowed)
- •Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment
- •Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from this trial if they have:
- •Prior treatment with any systemic chemotherapy for metastatic disease
- •Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study
- •Previous treatment with gemcitabine
- •Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion
- •Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
- •Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis
- •Known HIV or AIDS
- •Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol
- •History of malignancy other than pancreatic cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years
- •Major surgical procedure or significant traumatic injury within 4 weeks of treatment
- •Female patients must be surgically sterilised or postmenopausal or agree to use two adequate contraception measures during the period of therapy and continued for 6 months after the last dose of gemcitabine. Male patients must be surgically sterilised or agree to use adequate contraception for the same period.
- •Patients deemed unsuitable for gemcitabine chemotherapy
研究者
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