Trial information

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

Status: No longer 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 3450.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study

Condition: Colorectal Cancer

Intervention type: Drug

Intervention name: bevacizumab[Avastin]

Primary outcome: 1. Disease-free survival

Key secondary outcomes: 1. Efficacy: Overall survival. Safety: Adverse events and laboratory abnormalities.

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: December, 2004

Trial registration date: 06/24/2005

Date last updated: 9/29/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Adelaide
• Brisbane
• Fitzroy
• Malvern
• Melbourne
• Perth
• Sydney
• Wollongong

Austria

• Graz
• Wien

Belgium

• Bruxelles
• Gent
• Leuven

Brazil

• Porto Alegre
• Rio De Janeiro
• Sao Paulo
• Sorocaba

Bulgaria

• Plovdiv
• Sofia
• Stara Zagora
• Varna

Canada

• Edmonton, AB
• Kelowna, BC
• Surrey, BC
• Vancouver, BC
• Victoria, BC
• Winnipeg, MB
• Moncton, NB
• Sydney, NS
• Brampton, ON
• London, ON
• Oshawa, ON
• Ottawa, ON
• Thunder Bay, ON
• Toronto, ON
• Greenfield Park, QC
• Levis, QC
• Montreal, QC
• Quebec City, QC

China

• Beijing
• Guangzhou
• Hangzhou
• Hong Kong
• Shanghai

Czech Republic

• Brno
• Praha

Finland

• Helsinki
• Oulu
• Turku

France

• Angers
• Avignon
• Besancon
• Bobigny
• Bordeaux
• Caen
• Clichy
• Colmar
• Creteil
• Dijon
• La Roche Sur Yon
• Le Mans
• Lille
• Limoges
• Lorient
• Lyon
• Marseille
• Metz
• Montfermeil
• Montpellier
• Nice
• Paris
• Rennes
• Saint Gregoire
• Saint Herblain
• Senlis
• Strasbourg
• Suresnes
• Toulouse
• Tours

Germany

• Augsburg
• Berlin
• Bochum
• Bremen
• Dortmund
• Essen
• Frankfurt Am Main
• Freiburg
• Göttingen
• Herne
• Hildesheim
• Kaiserslautern
• Karlsruhe
• Köln
• Leverkusen
• Ludwigshafen
• Magdeburg
• Mainz
• Mannheim
• München
• Münchengladbach
• Oldenburg
• Porta Westfalica
• Regensburg
• Stuttgart
• Trier
• Tübingen

Greece

• Athens
• Patras
• Thessaloniki

Hungary

• Budapest
• Debrecen
• Szeged

Israel

• Haifa
• Jerusalem
• Kfar Saba
• Petah Tikva
• Ramat Gan
• Rehovot
• Tel Aviv

Italy

• Ancona
• Aviano
• Bari
• Bergamo
• Brescia
• Cattolica
• Genova
• Legnago
• Livorno
• Milano
• Modena
• Napoli
• Noale
• Orbassano
• Padova
• Parma
• Pavia
• Perugia
• Pisa
• Ravenna
• Reggio Emilia
• Rimini
• Roma
• Rozzano
• Sassari
• Taormina
• Udine
• Varese

Japan

• Chiba
• Hokkaido
• Osaka
• Shizuoka
• Tochigi
• Tokyo

Korea, Republic of

• Kyunggi Do
• Seoul

Mexico

• Chihuahua
• Merida
• Mexico City
• Monterrey
• Obregon

Netherlands

• Amersfoort
• Amsterdam
• Eindhoven
• Groningen

New Zealand

• Auckland
• Palmerston North

Norway

• Bergen
• Stavanger

Panama

• Panama City

Poland

• Bialystok
• Lodz
• Lublin
• Olsztyn
• Poznan
• Warszawa

Portugal

• Lisboa
• Porto

Russian Federation

• Kazan
• Moscow
• Samara
• St Petersburg

Singapore

• Singapore

South Africa

• Cape Town
• Johannesburg
• Pretoria

Spain

• Alicante
• Barcelona
• Córdoba
• Elche
• Girona
• Madrid
• Malaga
• Santander
• Valencia
• Zaragoza

Sweden

• Linkoeping
• Umea
• Västerås

Switzerland

• Basel
• Bellinzona
• Geneve
• Lausanne

Taiwan

• Taipei

Thailand

• Bangkok
• Khon Kaen

United Kingdom

• Aberdeen
• Bristol
• Bury St Edmunds
• Cambridge
• Denbigh
• Glasgow
• Guildford
• Leicester
• London
• Maidstone
• Manchester
• Newcastle upon Tyne
• Northwood
• Salisbury
• Sheffield
• Southampton
• Sutton

United States

• Alhambra, CA
• Bakersfield, CA
• Fullerton, CA
• Long Beach, CA
• Los Angeles, CA
• Northridge, CA
• Pomona, CA
• Redondo Beach, CA
• Santa Barbara, CA
• Santa Maria, CA
• Vista, CA
• Denver, CO
• Ocala, FL
• Atlanta, GA
• Marietta, GA
• Peoria, IL
• Indianapolis , IN
• Terre Haute, IN
• Columbia, MD
• Minneapolis, MN
• Kansas City, MO
• Las Vegas, NV
• Hudson, NY
• Raleigh, NC
• Winston-Salem, NC
• Eugene, OR
• Kingston , PA
• Dallas, TX
• Fort Worth, TX
• Houston, TX
• Tyler, TX
• Norfolk , VA
• Burien, WA
• Yakima, WA