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 sites70 target enrollmentAugust 31, 2010

Overview

Registry

who.int

Start Date

August 31, 2010

End Date

September 1, 2016

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Christie NHS Foundation Trust (UK)

•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

•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