Trial information

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

Status: No longer recruiting

Protocol number: MO18024

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: First-line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum. First BEAT (Bevacizumab Expanded Access Trial)

Brief summary: This expanded access study will evaluate the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as first-line treatment for metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 2000.

Study phase: IV

Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study

Condition: Colorectal Cancer

Intervention type: Drug

Intervention name: bevacizumab[Avastin]

Primary outcome: 1. Safety: Incidence of serious and specific adverse events

Key secondary outcomes: 1. Efficacy: Duration of survival; time to disease progression

Inclusion criteria:

• previously untreated metastatic colon or rectal cancer;
• scheduled to begin fluoropyrimidine-based chemotherapy as a first-line treatment;
• women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry;
• women of childbearing potential must use adequate contraception up to at least 6 months after last treatment completion, or the last drug dose, whichever occurs first.

Exclusion criteria:

• prior chemotherapy for metastatic colon or rectal cancer;
• planned radiotherapy for underlying disease;
• central nervous system metastases;
• major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of study;
• treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: June, 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:

Algeria

• Alger

Argentina

• Bahia Blanca
• Buenos Aires
• Córdoba
• La Plata
• Rosario
• San Miguel De Tucuman
• Santa Fe

Australia

• Adelaide
• Brisbane
• Darlinghurst
• Fremantle
• Heidelberg
• Kingswood
• St. Leonards
• Sydney
• Waratah
• Wodonga

Austria

• Graz
• Innsbruck
• Klagenfurt
• Leoben
• Salzburg
• Vöcklabruck
• Wien

Bangladesh

• Dhaka

Belgium

• Antwerpen
• Arlon
• Brasschaat
• Bruxelles
• Charleroi
• Edegem
• Genk
• Gent
• Kortrijk
• Leuven
• Libramont
• Liege
• Mont-Godinne
• Wilrijk

Brazil

• Belo Horizonte
• Brasilia
• Campinas
• Curitiba
• Fortaleza
• Ijuí
• Porto Alegre
• Recife
• Ribeirão Preto
• Rio De Janeiro
• Salvador
• Sao Paulo

Bulgaria

• Sofia

Canada

• Calgary, AB
• Edmonton, AB
• Kelowna, BC
• New Westminster, BC
• Surrey, BC
• Vancouver, BC
• Victoria, BC
• Winnipeg, MB
• Moncton, NB
• Sydney, NS
• Kingston, ON
• Oshawa, ON
• Ottawa, ON
• Toronto, ON
• Greenfield Park, QC
• Laval, QC
• Levis, QC
• Montreal, QC
• St-Jerome, QC
• Regina, SK
• Saskatoon, SK

Colombia

• Bogota

Ecuador

• Guayaquil
• Quito

Egypt

• Cairo

Finland

• Haemeenlinna
• Helsinki
• Joensuu
• Kotka
• Kuopio
• Lahti
• Oulu
• Vaasa

Germany

• Aschaffenburg
• Augsburg
• Berlin
• Dessau
• Dresden
• Essen
• Frankfurt Am Main
• Fulda
• Hamburg
• Heidelberg
• Hildesheim
• Jena
• Köln
• Magdeburg
• Mönchengladbach
• München
• Münchengladbach
• Oldenburg
• Rostock
• Saarbrücken
• Stuttgart

Greece

• Athens
• Haidari
• Heraklion
• Neo Faliro
• Patras
• Thessaloniki

Hungary

• Budapest
• Debrecen
• Kecskemet
• Pecs
• Szeged

India

• Mumbai
• New Delhi

Ireland

• Cork
• Dublin

Israel

• Afula
• Ashkelon
• Beer Sheva
• Haifa
• Holon
• Jerusalem
• Kfar Saba
• Nahariya
• Netanya
• Petah Tikva
• Ramat Gan
• Rehovot
• Safed
• Tel Aviv
• Zerifin

Italy

• Bergamo
• Bologna
• Brescia
• Castelnuovo
• Catanzaro
• Fermo
• Ferrara
• Firenze
• Genova
• Livorno
• Mantova
• Milano
• Napoli
• Noale (Ve)
• Padova
• Perugia
• Roma
• Sassari
• Taormina
• Udine

Kuwait

• Kuwait

Lebanon

• Beirut

Lithuania

• Kaunas
• Klaipeda
• Vilnius

Mexico

• Guadalajara
• Mexico City
• Monterrey
• Toluca

Morocco

• Casablanca
• Rabat

Netherlands

• Amsterdam
• Den Haag
• Eindhoven
• Groningen
• Leiden
• Nieuwegein
• Utrecht
• Zwolle

Norway

• Bergen
• Oslo
• Stavanger

Poland

• Gliwice
• Lublin
• Olsztyn
• Poznan
• Warszawa
• Wroclaw

Portugal

• Coimbra
• Lisboa
• Porto
• Setubal

Romania

• Bucharest
• Cluj-Napoca
• Craiova
• Timisoara

Russian Federation

• Ekaterinburg
• Engels
• Irkutsk
• Kazan
• Krasnodar
• Moscow
• Obninsk
• Smolensk
• St Petersburg
• Stavropol
• Tumen

Saudi Arabia

• Jeddah
• Riyadh

Slovakia

• Bratislava

Slovenia

• Ljubljana

Spain

• Alcorcon
• Alicante
• Badajoz
• Barcelona
• El Palmar Murcia
• Elche
• Girona
• Huelva
• Huesca
• Jaen
• La Coruna
• Lleida
• Lugo
• Madrid
• Murcia
• Oviedo
• Palma de Mallorca
• Pamplona
• Sabadell
• Sagunto
• Salamanca
• Santander
• Sevilla
• Terrassa
• Toledo
• Valencia

Sweden

• Goeteborg
• Linkoeping
• Lund
• Oerebro
• Stockholm

Switzerland

• Bellinzona
• Chur
• Neuchatel
• St Gallen

Turkey

• Istanbul

United Kingdom

• Belfast
• Birmingham
• Cardiff
• Edinburgh
• Leeds
• London
• Manchester
• Northwood
• Nottingham
• Sutton
• Torquay

Uruguay

• Montevideo