Clinical Trial Protocol Registry

Trial information

A Study of Avastin (Bevacizumab) Added to Various Chemotherapy Regimens in Patients With Colon Cancer

Status:
Active, not recruiting
Protocol number:
BO17920
Sponsor:
F. Hoffmann-La Roche AG/Roche Global Development
Company division:
Pharmaceutical
Official Scientific Title:
A randomized, open-label study of the effect of Avastin in combination with either capecitabine plus oxaliplatin (Xelox) or fluorouracil/leucovorin with oxaliplatin (Folfox-4) on disease-free survival in patients with colon cancer
Brief summary:
This study will evaluate the efficacy and safety of Avastin added to various combination regimens as adjuvant chemotherapy in chemotherapy-naive patients with colon cancer, who have had surgery. The anticipated time of study treatment is 6-12 months, and the target sample size is 500+ individuals. Target sample size is 3449.
Study phase:
III
Study type:
Interventional; Treatment; Randomized; Active; Parallel; Safety/efficacy study
Conditions:
  • Colorectal Cancer
Intervention type:
Drug
Intervention name:
bevacizumab [Avastin]
Primary outcome:
  1. Disease-free survival\n
Key secondary outcomes:
  1. Efficacy: Overall survival.\nSafety: Adverse events and laboratory abnormalities.\n
Inclusion criteria:
  • adult patients;
  • >=18 years of age;
  • documented colon carcinoma;
  • not a candidate for (neo) adjuvant radiotherapy;
  • curative surgery not less than 4 and not more than 8 weeks prior to study randomization.
Exclusion criteria:
  • evidence of metastatic disease;
  • previous anti-angiogenic treatment for any malignancy;
  • previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer;
  • pregnant or lactating women;
  • fertile men, or women of childbearing potential, not using adequate contraception;
  • major surgical procedures, open biopsy, or significant traumatic injury, within 28 days prior to study treatment start;
  • current or recent treatment (within 28 days prior to randomization) with another investigational drug, or participation in another investigational study.
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
May, 2003
Trial registration date:
19.12.2005
Date last updated:
05.12.2011
This trial was conducted at the following locations:
Australia
  • ADELAIDE
  • FITZROY
  • FOOTSCRAY
  • KURRALTA PARK
  • MALVERN
  • MELBOURNE
  • MILTON
  • PERTH
  • SYDNEY
  • WOLLONGONG
Austria
  • GRAZ
  • WIEN
Belgium
  • BRUXELLES
  • GENT
  • LEUVEN
BELGIUM
  • CHIMAY
Brazil
  • PORTO ALEGRE
  • RIO DE JANEIRO
  • SAO PAULO
  • SOROCABA
BRAZIL
  • Sao Paulo, SP
Bulgaria
  • PLOVDIV
  • SOFIA
  • STARA ZAGORA
  • VARNA
Canada
  • EDMONTON, AB
  • KELOWNA, BC
  • SURREY, BC
  • VANCOUVER, BC
  • VICTORIA, BC
  • MONCTON, NB
  • SYDNEY, NS
  • BRAMPTON, ON
  • LONDON, ON
  • OSHAWA, ON
  • THUNDER BAY, ON
  • TORONTO, ON
  • GREENFIELD PARK, QC
  • LEVIS, QC
  • MONTREAL, QC
  • QUEBEC CITY, QC
CANADA
  • Winnipeg, Manit
  • OTTAWA, Ontar
  • TORONTO, Ontar
China
  • BEIJING
  • GUANGZHOU
  • SHANGHAI
CHINA
  • Hangzhou
Czech Republic
  • BRNO
  • PRAHA
Finland
  • HELSINKI
  • OULU
  • TURKU
France
  • ANGERS
  • ARGENTEUIL
  • AVIGNON
  • BESANCON
  • BOBIGNY
  • BORDEAUX
  • CAEN
  • CHATEAUROUX
  • CLICHY
  • COLMAR
  • CRETEIL
  • DIJON
  • LAGNY-SUR-MARNE
  • LA ROCHE SUR YON
  • LE MANS
  • LILLE
  • LIMOGES
  • LORIENT
  • LYON
  • METZ
  • MONTPELLIER
  • MULHOUSE
  • NICE
  • PARIS
  • PAU
  • RENNES
  • ROUEN
  • SAINT GREGOIRE
  • SAINT HERBLAIN
  • STRASBOURG
  • SURESNES
  • TOULOUSE
  • TOURS
  • VILLEJUIF
FRANCE
  • HYERES
  • LE COUDRAY
  • Marseille
  • Paris
  • REIMS
  • Senlis
Germany
  • AUGSBURG
  • BERLIN
  • BOCHUM
  • DORTMUND
  • ESSEN
  • FRANKFURT
  • FRANKFURT AM MAIN
  • FREIBURG
  • GÖTTINGEN
  • HERNE
  • HILDESHEIM
  • HOMBURG/SAAR
  • KARLSRUHE
  • KÖLN
  • LEVERKUSEN
  • LUDWIGSHAFEN
  • MAGDEBURG
  • MAGEDBURG
  • MAINZ
  • MANNHEIM
  • MÖNCHENGLADBACH
  • MUENCHEN
  • MÜNCHEN
  • OLDENBURG
  • REGENSBURG
  • STUTTGART
  • TRIER
  • TÜBINGEN
GERMANY
  • Bremen
  • Kaiserslautern
  • Kiel
  • Oldenburg
  • Porta Westfalica
Greece
  • PATRAS
  • THESSALONIKI
GREECE
  • ATHENS
  • THESSALONIKI
Hong Kong
  • HONG KONG
Hungary
  • BUDAPEST
  • DEBRECEN
  • SZEGED
Israel
  • HAIFA
  • JERUSALEM
  • KFAR SABA
  • PETACH TIKVA
  • RAMAT-GAN
  • REHOVOT
  • TEL AVIV
Italy
  • ANCONA
  • AVIANO
  • BARI
  • BERGAMO
  • BRESCIA
  • CATTOLICA
  • GENOVA
  • LEGNAGO
  • LIVORNO
  • MILANO
  • MIRANO
  • MODENA
  • NAPOLI
  • ORBASSANO
  • PADOVA
  • PARMA
  • PAVIA
  • PERUGIA
  • PISA
  • RAVENNA
  • REGGIO EMILIA
  • RIMINI
  • ROMA
  • ROZZANO
  • SASSARI
  • TAORMINA
ITALY
  • MILANO
  • Udine
  • Varese
Japan
  • CHIBA
  • HOKKAIDO
  • OSAKA
  • SHIZUOKA
  • TOCHIGI
JAPAN
  • Tokyo
KOREA, REPUBLIC OF
  • SEOUL
Mexico
  • CHIHUAHUA
  • MERIDA
  • MEXICO CITY
  • MEXICO DF
  • MONTERREY
  • OBREGON
Netherlands
  • AMERSFOORT
  • AMSTERDAM
  • EINDHOVEN
  • UTRECHT
NETHERLANDS
  • Groningen
New Zealand
  • AUCKLAND
  • PALMERSTON NORTH
Norway
  • BERGEN
  • STAVANGER
Panama
  • PANAMA CITY
Poland
  • BIALYSTOK
  • LUBLIN
  • POZNAN
  • WARSZAWA
POLAND
  • LODZ
  • OLSZTYN
  • WARSZAWA
Portugal
  • LISBOA
  • PORTO
Republic of Korea
  • GYEONGGI-DO
  • SEOUL
Russian Federation
  • KAZAN
  • MOSCOW
  • SAMARA
  • ST PETERSBURG
Singapore
  • SINGAPORE
South Africa
  • CAPE TOWN
  • JOHANNESBURG
  • PRETORIA
SOUTH AFRICA
  • Johannesburg
  • Pretoria
Spain
  • ALICANTE
  • BARCELONA
  • CORDOBA
  • ELCHE
  • GIRONA
  • MADRID
  • SANTANDER
  • VALENCIA
  • ZARAGOZA
SPAIN
  • Barcelona, BARCE
  • Malaga, MALAG
  • MALAGA, MALAG
Sweden
  • LINKOEPING
  • VÄSTERÅS
SWEDEN
  • UMEA
Switzerland
  • BASEL
  • BELLINZONA
  • GENEVE
SWITZERLAND
  • Lausanne
TAIWAN
  • TAIPEI
Thailand
  • BANGKOK
THAILAND
  • KHON KAEN
U.S.A.
  • ALHAMBRA, CA
  • BAKERSFIELD, CA
  • FULLERTON, CA
  • LONG BEACH, CA
  • NORTHRIDGE, CA
  • OXNARD, CA
  • POMONA, CA
  • REDONDO BEACH, CA
  • SANTA BARBARA, CA
  • VISTA, CA
  • OCALA, FL
  • ORLANDO, FL
  • ATLANTA, GA
  • MARIETTA, GA
  • PEORIA, IL
  • INDIANAPOLIS, IN
  • TERRE HAUTE, IN
  • COLUMBIA, MD
  • KANSAS CITY, MO
  • RALEIGH, NC
  • LAS VEGAS, NV
  • HUDSON, NY
  • KETTERING, OH
  • SPRINGFIELD, OR
  • KINGSTON, PA
  • DALLAS, TX
  • HOUSTON, TX
  • THE WOODLANDS, TX
  • TYLER, TX
  • NORFOLK, VA
  • BURIEN, WA
  • SPOKANE, WA
United Kingdom
  • ABERDEEN
  • DENBIGH
  • GLASGOW
  • GUILDFORD
  • LEICESTER
  • LONDON
  • MANCHESTER
  • NEWCASTLE UPON TYNE
  • NORTHWOOD
  • SALISBURY
  • SHEFFIELD
  • SOUTHAMPTON
  • SUTTON
  • WESTON SUPER MARE
UNITED KINGDOM
  • BURY ST EDMUNDS
  • CAMBRIDGE
  • LONDON
  • Maidstone
UNITED STATES
  • LOS ANGELES, CA
  • San Luis Obispo, CA
  • Santa Barbara, CA
  • DENVER, CO
  • SNELLVILLE, GA
  • Minneapolis, MN
  • Greensboro, NC
  • Winston-Salem, NC
  • Dallas, TX
  • YAKIMA, WA

Link to trial result

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