EUCTR2005-004519-32-AT进行中（未招募）1 期
A randomised controlled pilot study of the efficacy of adding bevacizumab to gemcitabine as neoadjuvant treatment for locally advanced non metastatic pancreatic cancer - Neo-Avastin
Medical University Vienna, Dept. of surgery0 个研究点目标入组 20 人开始时间: 2005年10月24日最近更新:
适应症
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
- 20
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
- 性别
- All
入选标准
- •1.Have provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •2.Age = 18 years
- •3.Karnofsky Performance Status (KPS) = 60
- •4.Life expectancy = 8 weeks
- •5.Absolute neutrophil count = 1500/mm3
- •6.Adequate liver function:
- •-Serum (total) bilirubin = 1.5 x ULN, AST & ALT = 2.5 x ULN, Albumin = 2.5 g/dl.
- •-Alk Phos = 2.5 ULN. If Alk Phos is > 2.5 ULN, SGOT (AST) and SGPT (ALT) must be = 1.5 ULN.
- •7.Creatinine levels = 2mg/dl (positive urine protein dipstick of = 2+ at baseline must have = 1 g/24 hr protein)
- •8.Negative pregnancy test
- •9.Histologically or cytologically documented pancreatic cancer (adenocarcinoma) staged T4 (stage III) according to the 6th edition of the TNM classification
- •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
- •1. Early (Stage IA to IIB) pancreatic cancer and metastatic (Stage IV) pancreatic cancer (as defined in Appendix 2)
- •2.Previous systemic therapy for pancreatic cancer
- •3.Other primary tumour (including primary brain tumours) within the last 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer
- •4.CT-scan based evidence of tumour invading major blood vessels (putting patients at risk of bleeding during trial treatment)
- •5.Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgery during the course of the study treatment
- •6.Current or recent (within 10 days of Is' dose of study treatment) chronic use of aspirin (>325 mg/day)
- •7.Current or recent (within 10 days of Is' dose of study treatment) chronic use of full therapeutic dose of oral or parenteral anticoagulants or thrombolytic agents
- •8.Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (< 6 months prior to randomisation), myocardial infarction (< 6 months prior to randomisation), unstable angina, New York Heart Association NYHA (Appendix 3) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- •9.History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •10.Non-healing wound, ulcer, or bone fracture, patients with oesophageal varices
- •11.Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
- •12.Inability to take oral medication, prior surgical procedures affecting absorption or resulting in the requirement for iv alimentation or parenteral nutrition with lipids, and/or active peptic ulcer disease
- •13.Pregnant or lactating females; serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start
- •14.Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
- •15.Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or patient at high risk from treatment complications
- •16.Known hypersensitivity to any of the study drugs
- •17.Unwilling or unable to comply with the protocol for the duration of the study
研究者
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