ISRCTN97323814已完成2 期
An assessment of imaging and circulating biomarkers in patients with metastatic colorectal carcinoma treated with the anti-vascular endothelial growth factor (anti-VEGF) antibody, bevacizumab
The Christie NHS Foundation Trust (UK)0 个研究点目标入组 70 人开始时间: 2010年8月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
- 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30405103 (added 31/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 18 years old, either sex
- •2. Signed informed consent and ability to comply with study protocol
- •3. Histologically confirmed colorectal cancer.
- •4. Previously untreated metastatic disease
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •6. Life expectancy greater than 12 weeks
- •7. Adequate bone marrow function: absolute neutrophil count (ANC) more than 1.5 x 10^9/L; platelets more than or equal to 100 x 10^9/L; haemoglobin (Hb) more than or equal to 9 g/dL (can be post-transfusion)
- •8. International normalised ratio (INR) less than or equal to 1.5 and activited partial thromboplastin time (aPTT) less than or equal to 1.5 x upper limit of normal (ULN) within 7 days prior to starting study treatment
- •9. Adequate liver function: serum bilirubin less than or equal to 1.5 x ULN except in case of known Gilbert syndrome; transaminases less than or equal to 2.5 x ULN in the absence of liver metastases or less than or equal to 5 x ULN in the presence of liver metastases
- •10. Adequate renal function: estimated glomerular filtration rate greater than or equal to 50 ml/min by the Wright Formula
- •11. Urine dipstick for proteinuria less than or equal to 2+. If urine dipstick is more than or equal to 2+, a 24-hour urine must demonstrate less than 1 g of protein in 24 hours
- •12. At least one metastatic deposit in the abdomen (including inguinal lymphadenopathy) liver, retroperitoneum, pelvis or thorax greater than or equal to 3 cm diameter
- •13. No contraindications to magnetic resonance imaging (MRI) scanning or allergy to gadolininum-containing contrast media
排除标准
- •1. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab
- •2. Significant traumatic injury or radiotherapy during 4 weeks preceding potential first dose of bevacizumab
- •3. Adjuvant therapy within the previous 12 months
- •4. Patients with previous adjuvant exposure to oxaliplatin can only take part if it is more than 12 months since their last exposure to oxaliplatin and they have grade I or less, residual peripheral neuropathy
- •5. No previous exposure to VEGF inhibitors in the adjuvant setting
- •6. History or evidence upon physical examination of brain metastases. Evidence of spinal cord compression. Computed tomography (CT)/MRI of the brain is mandatory (within 4 weeks prior to randomisation) in case of clinical evidence of brain metastases.
- •7. Pregnant or breast-feeding women. Positive pregnancy test (serum or urine beta-human chorionic gonadotropin [ß-HCG]) for women of reproductive potential
- •8. Fertile woman of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •9. Other malignancies within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer
- •10. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this trial
- •11. Known hypersensitivity to bevacizumab, 5-fluorouracil, capecitabine, oxaliplatin or irinotecan
- •12. Known dihydro-pyrimidine dehydrogenase deficiency
- •13. Non-healing wound, ulcer or bone fracture
- •14. Patients cannot enter the trial if they have developed a deep venous thrombosis (DVT) or commenced therapeutic anticoagulation for any other reason, e.g., atrial fibrillation (AF) within the 4 weeks preceding the trial. Patients with a known DVT or AF on stable therapeutic doses of low molecular weight heparin for greater than 4 weeks duration, can enter the trial.
- •15. Patients with haemorrhagic disorders
- •16. Poorly controlled hypertension (sustained blood pressure [BP] greater than 150/100 mmHg despite antihypertensive therapy
- •17. Previous cerebrovascular accident (CVA), transient ischaemic attack (TIA) or subarachnoid haemorrhage (SAH) within six months before trial entry
- •18. Clinically significant cardiovascular disease, for example:
- •18.1. Myocardial infarction or unstable angina within 6 months of trial entry
- •18.2. New York Heart Association (NYHA) grade 2 or worse congestive heart failure (CHF)
- •18.3. Poorly controlled cardiac arrhythmia despite medication
- •19. Current or recent (within 10 days prior to first dose of trial treatment) use of aspirin greater than or equal to 325 mg/day
- •20. Pre-existing sensory or motor neuropathy greater than or equal to grade 2, uncontrolled spinal cord compression, or
- •21. Carcinomatous meningitis or new evidence of brain or leptomeningeal disease
- •22. Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline of greater than 3 loose stools
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