Clinical trial NCT00484939: A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-06-12
Enrollment: 280
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 70 years of age.
* Cancer of the colon or rectum.
* Metastatic disease diagnosed ≤ 6 months before enrollment.
* ≥ 1 measurable metastatic lesion.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: Duration of Response
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: Time to Response
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).
measure: Percentage of Participants Requiring Additional Treatment for Malignancy
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: Duration of Follow-up
timeFrame: Baseline to the end of the study (up to 5 years 8 months)
measure: AEs, Laboratory Parameters, Vital Signs
timeFrame: Throughout study
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Larissa
country: Greece
city: Piraeus
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Zalaegerszeg-Pozva
country: Hungary
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Lecce
country: Italy
state: Puglia
city: Firenze
country: Italy
state: Toscana
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Leon
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Puebla
country: Mexico
city: Apeldoorn
country: Netherlands
city: Eindhoven
country: Netherlands
city: Utrecht
country: Netherlands
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Warszawa
country: Poland
city: Ljubljana
country: Slovenia
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Leganes
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Zaragoza
country: Spain
city: Bristol
country: United Kingdom
city: Colchester
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Rhyl
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.