drugset / Trial / NCT01229813

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

NCT01229813

Phase 3 Completed 233 enrolled Lund University Hospital Hoffmann-La Roche · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-10
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 7.5 mg/kg
Comparator Capecitabine Small molecule 500 mg
Comparator Erlotinib Small molecule 150 mg

Indications