A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
NCT ID: NCT00484939
Last Updated: 2015-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2007-07-31
2013-03-31
Brief Summary
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No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.
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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 + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Bevacizumab
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Capecitabine
Participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Interventions
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Bevacizumab
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Bevacizumab was supplied in single-use vials.
Capecitabine
Treatment continued until unacceptable toxicity, withdrawal of consent, disease progression, or a decision to terminate at the discretion of the Investigator if medically indicated. Capecitabine was supplied as tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cancer of the colon or rectum.
* Metastatic disease diagnosed ≤ 6 months before enrollment.
* ≥ 1 measurable metastatic lesion.
Exclusion Criteria
* Prior chemotherapeutic treatment for metastatic colorectal cancer.
* Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
* Clinically significant cardiovascular disease.
* Current or recent daily use of aspirin (\> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Innsbruck, , Austria
Linz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Larissa, , Greece
Piraeus, , Greece
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Zalaegerszeg-Pozva, , Hungary
Lecce, Apulia, Italy
Reggio Emilia, Emilia-Romagna, Italy
Rome, Lazio, Italy
Florence, Tuscany, Italy
León, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Puebla City, , Mexico
Apeldoorn, , Netherlands
Eindhoven, , Netherlands
Utrecht, , Netherlands
Krakow, , Poland
Krakow, , Poland
Warsaw, , Poland
Ljubljana, , Slovenia
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Jaén, Jaen, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Leganés, Madrid, Spain
Madrid, Madrid, Spain
Murcia, Murcia, Spain
Zaragoza, Zaragoza, Spain
Bristol, , United Kingdom
Colchester, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Rhyl, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Cunningham D, Lang I, Marcuello E, Lorusso V, Ocvirk J, Shin DB, Jonker D, Osborne S, Andre N, Waterkamp D, Saunders MP; AVEX study investigators. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1077-1085. doi: 10.1016/S1470-2045(13)70154-2. Epub 2013 Sep 10.
Other Identifiers
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MO19286
Identifier Type: -
Identifier Source: org_study_id
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