Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
bevacizumab 7.5 mg/kg body weight every third week
bevacizumab 7.5 mg/kg body weight every third week.
capecitabine 500 mg twice daily
University Hospital
Odense, Denmark
County Hospital Ryhov
Jönköping, Sweden
County Hospital
Kalmar, Sweden
Central Hospital
Karlstad, Sweden
University Hospital
Linköping, Sweden
Skåne University Hospital-Lund
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Sundsvall Hospital
Sundsvall, Sweden
Norrland University Hospital
Umeå, Sweden
Akademiska Hospital
Uppsala, Sweden
...and 2 more locations
To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab.
Time frame: 3 years
To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.
Time frame: 3 years
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