A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer
1 other identifier
interventional
280
12 countries
55
Brief Summary
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle) alone. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 colorectal-cancer
Started Jul 2007
Typical duration for phase_3 colorectal-cancer
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2007
CompletedFirst Posted
Study publicly available on registry
June 12, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 10, 2014
CompletedJanuary 8, 2015
January 1, 2015
5.7 years
June 11, 2007
March 7, 2014
January 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
Baseline to the end of the study (up to 5 years 8 months)
Secondary Outcomes (8)
Best Overall Response (BOR)
Baseline to the end of the study (up to 5 years 8 months)
Duration of Response
Baseline to the end of the study (up to 5 years 8 months)
Time to Response
Baseline to the end of the study (up to 5 years 8 months)
Overall Survival
Baseline to the end of the study (up to 5 years 8 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
- +3 more secondary outcomes
Study Arms (2)
Bevacizumab + capecitabine
EXPERIMENTALParticipants 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.
Capecitabine
ACTIVE COMPARATORParticipants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Adult patients, ≥ 70 years of age.
- Cancer of the colon or rectum.
- Metastatic disease diagnosed ≤ 6 months before enrollment.
- ≥ 1 measurable metastatic lesion.
You may not qualify if:
- Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Unknown Facility
Innsbruck, 6020, Austria
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Linz, 4010, Austria
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Salzburg, 5020, Austria
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Vienna, 1160, Austria
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Vienna, 1220, Austria
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Calgary, Alberta, T2N 4N2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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London, Ontario, N6A 4L6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Larissa, 41 110, Greece
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Piraeus, 18537, Greece
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Budapest, 1083, Hungary
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Budapest, 1122, Hungary
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Győr, 9023, Hungary
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Zalaegerszeg-Pozva, 8900, Hungary
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Lecce, Apulia, 73100, Italy
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Reggio Emilia, Emilia-Romagna, 42100, Italy
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Rome, Lazio, 00144, Italy
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Florence, Tuscany, 50139, Italy
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León, 37000, Mexico
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Mexico City, 14000, Mexico
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Mexico City, 14140, Mexico
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Mexico City, 16200, Mexico
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Puebla City, 72530, Mexico
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Apeldoorn, 7334 DZ, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Utrecht, 3527 CE, Netherlands
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Krakow, 30-501, Poland
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Krakow, 31-826, Poland
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Warsaw, 02-097, Poland
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Ljubljana, 1000, Slovenia
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Gyeonggi-do, 410-769, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110-744, South Korea
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Seoul, 135-710, South Korea
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Barcelona, Barcelona, 08041, Spain
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Jaén, Jaen, 23007, Spain
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Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
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Leganés, Madrid, 28911, Spain
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Madrid, Madrid, 28040, Spain
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Murcia, Murcia, 30120, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Bristol, BS2 8ED, United Kingdom
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Colchester, CO3 3NB, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Rhyl, LL18 5UJ, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (1)
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.
PMID: 24028813DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2007
First Posted
June 12, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
January 8, 2015
Results First Posted
June 10, 2014
Record last verified: 2015-01