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

NCT01229813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2015-04-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229813 on ClinicalTrials.gov