NCT01229813

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab, erlotinib	bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
DRUG	bevacizumab	bevacizumab 7.5 mg/kg body weight every third week
DRUG	bevacizumab	bevacizumab 7.5 mg/kg body weight every third week.
DRUG	low dose capecitabine	capecitabine 500 mg twice daily

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-10-28
• Last updated: 2015-04-13

Locations

12 sites across 2 countries: Denmark, Sweden