Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.
NCT ID: NCT01229813
Last Updated: 2015-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
233 participants
INTERVENTIONAL
2010-10-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bevacizumab and erlotinib (KRAS WT)
bevacizumab, erlotinib
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
bevacizumab (KRAS WT)
bevacizumab
bevacizumab 7.5 mg/kg body weight every third week
bevacizumab (KRAS mutated)
bevacizumab
bevacizumab 7.5 mg/kg body weight every third week.
low dose capecitabine (KRAS mutated)
low dose capecitabine
capecitabine 500 mg twice daily
Interventions
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bevacizumab, erlotinib
bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
bevacizumab
bevacizumab 7.5 mg/kg body weight every third week
bevacizumab
bevacizumab 7.5 mg/kg body weight every third week.
low dose capecitabine
capecitabine 500 mg twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* CNS metastases
* Clinically significant atherosclerotic vascular disease
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Lund University Hospital
OTHER
Responsible Party
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Locations
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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
Central Hospital
Vaxjo, , Sweden
Central Hospital
Västerås, , Sweden
Countries
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References
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Hagman H, Frodin JE, Berglund A, Sundberg J, Vestermark LW, Albertsson M, Fernebro E, Johnsson A. A randomized study of KRAS-guided maintenance therapy with bevacizumab, erlotinib or metronomic capecitabine after first-line induction treatment of metastatic colorectal cancer: the Nordic ACT2 trial. Ann Oncol. 2016 Jan;27(1):140-7. doi: 10.1093/annonc/mdv490. Epub 2015 Oct 19.
Other Identifiers
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ML 25359
Identifier Type: -
Identifier Source: org_study_id
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