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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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:Australia - Adelaide
- Brisbane
- Fitzroy
- Malvern
- Melbourne
- Perth
- Sydney
- Wollongong
Austria Belgium 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 Finland 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 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 Mexico - Chihuahua
- Merida
- Mexico City
- Monterrey
- Obregon
Netherlands - Amersfoort
- Amsterdam
- Eindhoven
- Groningen
New Zealand - Auckland
- Palmerston North
Norway Panama Poland - Bialystok
- Lodz
- Lublin
- Olsztyn
- Poznan
- Warszawa
Portugal Russian Federation - Kazan
- Moscow
- Samara
- St Petersburg
Singapore South Africa - Cape Town
- Johannesburg
- Pretoria
Spain - Alicante
- Barcelona
- Córdoba
- Elche
- Girona
- Madrid
- Malaga
- Santander
- Valencia
- Zaragoza
Sweden Switzerland - Basel
- Bellinzona
- Geneve
- Lausanne
Taiwan Thailand 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
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