A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients \>/= 18 years of age
Histologically confirmed adenocarcinoma of the colon or rectum
Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
Tumour tissue sample available for assessment of K-RAS and BRAF genes
Prior radiotherapy must have been completed 4 weeks before randomization
Adequate bone marrow, kidney and liver function
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
You may not be if
Previous chemotherapy for metastatic disease
Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
Clinical or radiographic evidence of brain metastases
Clinically significant cardiovascular disease or disorder
History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
HIV, hepatitis B or C infection
Clareo Health | A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab