A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

Last updated: January 7, 2015
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Colon Cancer

Rectal Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00484939
MO19286
  • Ages > 70
  • All Genders

Study 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

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

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 andsquamous 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-steroidalanti-inflammatory drug (NSAID), or full dose anticoagulants.

Study Design

Total Participants: 280
Study Start date:
July 01, 2007
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Linz, 4010
    Austria

    Site Not Available

  • Salzburg, 5020
    Austria

    Site Not Available

  • Wien, 1160
    Austria

    Site Not Available

  • Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • London, Ontario N6A 4L6
    Canada

    Site Not Available

  • Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Larissa, 41 110
    Greece

    Site Not Available

  • Piraeus, 18537
    Greece

    Site Not Available

  • Budapest, 1122
    Hungary

    Site Not Available

  • Gyor, 9023
    Hungary

    Site Not Available

  • empty

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Zalaegerszeg-Pozva, 8900
    Hungary

    Site Not Available

  • Reggio Emilia, Emilia-Romagna 42100
    Italy

    Site Not Available

  • Roma, Lazio 00144
    Italy

    Site Not Available

  • Lecce, Puglia 73100
    Italy

    Site Not Available

  • Firenze, Toscana 50139
    Italy

    Site Not Available

  • empty

    Goyang-si, 410-769
    Korea, Republic of

    Site Not Available

  • Gyeonggi-do, 410-769
    Korea, Republic of

    Site Not Available

  • Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • empty

    Kyunggi-do, 410-769
    Korea, Republic of

    Site Not Available

  • Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Leon, 37000
    Mexico

    Site Not Available

  • Mexico City, 14140
    Mexico

    Site Not Available

  • Puebla, 72530
    Mexico

    Site Not Available

  • Apeldoorn, 7334 DZ
    Netherlands

    Site Not Available

  • Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Utrecht, 3527 CE
    Netherlands

    Site Not Available

  • Krakow, 30-501
    Poland

    Site Not Available

  • Warszawa, 02-097
    Poland

    Site Not Available

  • Ljubljana, 1000
    Slovenia

    Site Not Available

  • Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Site Not Available

  • Leganes, Madrid 28911
    Spain

    Site Not Available

  • Barcelona, 08041
    Spain

    Site Not Available

  • Jaen, 23007
    Spain

    Site Not Available

  • Madrid, 28040
    Spain

    Site Not Available

  • Murcia, 30120
    Spain

    Site Not Available

  • Zaragoza, 50009
    Spain

    Site Not Available

  • Bristol, BS2 8ED
    United Kingdom

    Site Not Available

  • Colchester, CO3 3NB
    United Kingdom

    Site Not Available

  • empty

    Denbigh, LL18 5UJ
    United Kingdom

    Site Not Available

  • Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • London, W2 1NY
    United Kingdom

    Site Not Available

  • Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Rhyl, LL18 5UJ
    United Kingdom

    Site Not Available

  • Sutton, SM2 5PT
    United Kingdom

    Site Not Available

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