The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,814
Progression Free Survival
Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Overall Survival
Number of months from randomisation to the date of death from any cause
Time frame: Randomisation until data cut-off
Objective Response Rate
Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below: CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Time frame: Up until data cut-off
Duration of Response
Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
Time frame: Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
Time frame: Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
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intravenous infusion
intravenous infusion
Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Casa Grande, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Palm Springs, California, United States
Research Site
San Diego, California, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Stamford, Connecticut, United States
Research Site
Bay Pines, Florida, United States
...and 270 more locations
Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.
Time frame: Baseline through to data cut-off