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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: bevacizumab, erlotinib; Drug: bevacizumab; Drug: low dose capecitabine

• Registration Number: NCT01229813
• Lead Sponsor: Lund University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Status Verified: 2013-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Untreated metastatic colorectal carcinoma
• Age 18 yrs or over
• Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria)
• ECOG performance status 0 or 1
• Life expectancy more than 3 months
• Adequate haematological, renal and liver function
• Tumor tissue available for determination of KRAS mutational status
• Blood sample and paraffin embedded tumor tissue for translational research

Exclusion Criteria

• Adjuvant therapy within 6 months
• CNS metastases
• Clinically significant atherosclerotic vascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bevacizumab and erlotinib (KRAS WT)	bevacizumab, erlotinib	-
bevacizumab (KRAS WT)	bevacizumab	-
low dose capecitabine (KRAS mutated)	low dose capecitabine	-
bevacizumab (KRAS mutated)	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
To explore the activity of bevacizumab and low dose metronomic capecitabine in patients with KRAS mutated tumors.	3 years

Trial Locations

Locations (9)

University Hospital; 🇸🇪 Linköping, Sweden

County Hospital; 🇸🇪 Kalmar, Sweden

County Hospital Ryhov; 🇸🇪 Jönköping, Sweden

Central Hospital; 🇸🇪 Växjö, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

Akademiska Hospital; 🇸🇪 Uppsala, Sweden

Skåne University Hospital-Lund; 🇸🇪 Lund, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Norrland University Hospital; 🇸🇪 Umeå, Sweden