AN ASSESSMENT OF IMAGING AND CIRCULATING BIOMARKERS IN PATIENTS WITH METASTATIC COLORECTAL CARCINOMA TREATED WITH THE ANTI-VEGF MONOCLONAL ANTIBODY BEVACIZUMAB - TRAVASTIN-1. Protocol version 4.0 (20.05.2011)
- Conditions
- Metastatic colorectal cancerMedDRA version: 14.0 Level: PT Classification code 10056417 Term: Monoclonal antibody unconjugated therapy System Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2009-011377-33-GB
- Lead Sponsor
- The Christie NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
INCLUSION CRITERIA 1.Age = 18 years old 2.Signed informed consent and ability to comply with study protocol 3.Histologically confirmed colorectal cancer. 4.Previously untreated metastatic disease 5.ECOG performance status 0-2 6.Life expectancy > 12 weeks 7.Adequate bone marrow function : ANC (Absolute Neutrophil Count) more than 1.5 x 109/L; Platelets more than or equal to 100 x 109/L; Hb more than or equal to 9 g/dL (can be post-transfusion) 8.INR less than or equal to 1.5 and aPTT less than or equal to 1.5 x 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 =5 x ULN in the presence of liver metastases. 10.Adequate renal function: Estimated glomerular filtration rate = 50ml/min by the Wright Formula 11.Urine dipstick for proteinuria < 2+. If urine dipstick is more than or equal to 2+, 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 = 3cm diameter. 13.No contraindications to MRI scanning or allergy to gadolininum- containing contrast media.
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
EXCLUSION CRITERIA 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. 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 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 BP >150/100mmHg 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 - myocardial infarction or unstable angina within 6 months of trial entry - NYHA grade 2 or worse congestive heart failure (CHF), - Poorly controlled cardiac arrhythmia despite medication 19.Current or recent (within 10 days prior to first dose of trial treatment) use of aspirin >/= 325 mg/day 20.Pre-existing sensory or motor neuropathy >/= 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 > 3 loose stools daily. 23.Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhoea, unresolved bowel obstruction/sub-obstruction, extensive small intestine resection with chronic diarrhoea. 24.History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with chemotherapy. 25.Patients with a colonic stent. 26.Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or con
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method