Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00384176
Other study ID # D8480C00013
Secondary ID Eudract Number 2
Status Completed
Phase Phase 2/Phase 3
First received October 3, 2006
Last updated April 13, 2017
Start date August 30, 2006
Est. completion date August 19, 2015

Study information

Verified date April 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.


Recruitment information / eligibility

Status Completed
Enrollment 1814
Est. completion date August 19, 2015
Est. primary completion date November 15, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria:

- Clinical Diagnosis of colon or rectal cancer

- No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.

Exclusion Criteria:

- Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.

- Poorly controlled hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cediranib
oral tablet once daily
Bevacizumab
intravenous infusion
5-fluorouracil ( in FOLFOX)
intravenous infusion
Leucovorin (in FOLFOX)
intravenous infusion
Oxaliplatin (in FOLFOX)
intravenous infusion

Locations

Country Name City State
Australia Research Site Armidale New South Wales
Australia Research Site Ashford
Australia Research Site Ashford South Australia
Australia Research Site Bedford Park South Australia
Australia Research Site Bedford Park
Australia Research Site Bendigo
Australia Research Site Box Hill
Australia Research Site Camperdown
Australia Research Site Coffs Harbour
Australia Research Site Coffs Harbour New South Wales
Australia Research Site Darlinghurst New South Wales
Australia Research Site Darlinghurst
Australia Research Site East-Melbourne
Australia Research Site Epping
Australia Research Site Epping Victoria
Australia Research Site Herston
Australia Research Site Hobart
Australia Research Site Hobart Tasmania
Australia Research Site Hornsby
Australia Research Site Hornsby New South Wales
Australia Research Site Kogarah New South Wales
Australia Research Site Kogarah
Australia Research Site Lismore
Australia Research Site Malvern
Australia Research Site Nedlands
Australia Research Site Port Macquarie
Australia Research Site Port Macquarie New South Wales
Australia Research Site Randwick New South Wales
Australia Research Site Randwick
Australia Research Site South Brisbane
Australia Research Site South Brisbane Queensland
Australia Research Site St. Leonards
Australia Research Site St. Leonards New South Wales
Australia Research Site Tamworth New South Wales
Australia Research Site Tamworth
Australia Research Site Waratah
Australia Research Site Waratah New South Wales
Australia Research Site Wodonga
Australia Research Site Woodville South
Australia Research Site Woodville South South Australia
Austria Research Site Innsbruck
Austria Research Site Kundratstrasse 3
Austria Research Site Kundratstrasse 3 Vienna
Austria Research Site Salzburg
Austria Research Site Wels
Austria Research Site Wien
Austria Research Site Zams
Belgium Research Site Bonheiden
Belgium Research Site Brugge
Belgium Research Site Brussels (woluwe-st-lambert)
Belgium Research Site Brussels (Woluwé-St-Lambert)
Belgium Research Site Edegem
Belgium Research Site Gent
Belgium Research Site Ghent
Belgium Research Site Kortrijk
Belgium Research Site Leuven
Belgium Research Site Roeselare
Canada Research Site Barrie Ontario
Canada Research Site Calgary Alberta
Canada Research Site Edmonton Alberta
Canada Research Site Levis Quebec
Canada Research Site Montreal Quebec
Canada Research Site Montreal
Canada Research Site Newmarket Ontario
Canada Research Site Quebec
Canada Research Site Scarborough Ontario
Canada Research Site St Catharines Ontario
Canada Research Site Sudbury Ontario
Canada Research Site Surrey British Columbia
Canada Research Site Sydney Nova Scotia
Canada Research Site Toronto Ontario
Canada Research Site Vancouver British Columbia
Canada Research Site York Ontario
Czech Republic Research Site Brno
Czech Republic Research Site Chomutov
Czech Republic Research Site Kutna Hora
Czech Republic Research Site Nova Ves pod Plesi
Czech Republic Research Site Pardubice
Czech Republic Research Site Tabor
Egypt Research Site Alexandria
Egypt Research Site Cairo
Finland Research Site Helsinki
Finland Research Site Tampere
Finland Research Site Turku
Finland Research Site Vaasa
France Research Site Boulogne Cedex
France Research Site La Roche S YON
France Research Site Marseille Cedex 08
France Research Site Nantes
France Research Site Nantes,
France Research Site Paris
France Research Site Paris Cedex 15
France Research Site Saint Gregoire
Germany Research Site Dresden
Germany Research Site Essen
Germany Research Site Freiburg
Germany Research Site Halle
Germany Research Site Hannover
Germany Research Site Heidelberg
Germany Research Site Munchen
Germany Research Site München
Germany Research Site Neu-isenburg
Germany Research Site Tubingen
Germany Research Site Tübingen
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Pecs
Hungary Research Site Pécs
Hungary Research Site Szeged
Hungary Research Site Tatabanya
Hungary Research Site Tatabánya
India Research Site Bangalore
India Research Site Bhopal
India Research Site Bhopal Madhya Pradesh
India Research Site Chennai
India Research Site Hyderabad
India Research Site Jaipur
India Research Site Jaipur Rajasthan
India Research Site Kolkata W Bengal
India Research Site Kolkata
India Research Site Mumbai
India Research Site Pune
India Research Site Pune Maharashtra
India Research Site Sheikhpura
India Research Site Varanasi Uttar Prad
Israel Research Site Holon
Israel Research Site Kfar-saba
Israel Research Site Petah Tikva
Israel Research Site Tel Aviv
Israel Research Site Tel-Hashomer
Israel Research Site Tiberias
Israel Research Site Tzrifin
Italy Research Site Ancona
Italy Research Site Genova
Italy Research Site Genova GE
Italy Research Site Napoli
Italy Research Site Roma
Italy Research Site Rozzano
Italy Research Site Rozzano MI
Latvia Research Site Riga
Malta Research Site Floriana
Malta Research Site Valletta
Philippines Research Site Cebu City
Philippines Research Site Davao City
Philippines Research Site Molo
Philippines Research Site Quezon City
Poland Research Site Bytom
Poland Research Site Elblag
Poland Research Site Gdynia
Poland Research Site Krakow
Poland Research Site Kraków
Poland Research Site Lublin
Poland Research Site Poznan
Poland Research Site Poznan
Poland Research Site Rybnik
Poland Research Site Warszawa
Russian Federation Research Site Barnaul
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Omsk
Russian Federation Research Site Tomsk
Russian Federation Research Site Tumen
Slovakia Research Site Bratislava
Slovakia Research Site Kosice
Slovakia Research Site Nitra
Slovakia Research Site Presov
South Africa Research Site Cape Town
South Africa Research Site Lyttelton Manor
South Africa Research Site Polokwane
South Africa Research Site Port Elizabeth
South Africa Research Site Pretoria
Spain Research Site A Coruna Galicia
Spain Research Site A Coruña
Spain Research Site Barcelona Cataluna
Spain Research Site Cordoba Andalucia
Spain Research Site Córdoba
Spain Research Site Granollers
Spain Research Site Granollers Cataluna
Spain Research Site Hospitalet de Llobregat(barcel Cataluna
Spain Research Site Hospitalet de Llobregat(Barcel
Spain Research Site Madrid
Spain Research Site Madrid Comunidad de Madrid
Spain Research Site Manresa
Spain Research Site Oviedo
Spain Research Site Oviedo Asturias
Spain Research Site Terrassa(barcelona) Cataluna
Spain Research Site Valencia
Spain Research Site Valencia Comunidad Valenciana
Spain Research Site Zaragoza
Spain Research Site Zaragoza Aragon
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Tao-yuan
Thailand Research Site Chiang Mai
Thailand Research Site Nakhonratchasima Naimuang
Thailand Research Site Rachathewi
Thailand Research Site Songkla
Turkey Research Site Ankara
Turkey Research Site Istanbul Goztepe
Turkey Research Site Izmir
Ukraine Research Site Cherkassy
Ukraine Research Site Chernigiv
Ukraine Research Site Chernivtsi
Ukraine Research Site Dnipropetrovsk
Ukraine Research Site Donetsk
Ukraine Research Site Ivano-Frankivsk
Ukraine Research Site Kharkiv
Ukraine Research Site Kharkov
Ukraine Research Site Kherson
Ukraine Research Site Kiev
Ukraine Research Site Kyiv
Ukraine Research Site Lugansk
Ukraine Research Site Lviv
Ukraine Research Site Poltava
Ukraine Research Site Simferopol
Ukraine Research Site Sumy
Ukraine Research Site Ternopil
Ukraine Research Site Ternopol
Ukraine Research Site Uzhgorod
United Kingdom Research Site Bebington
United Kingdom Research Site Bournemouth
United Kingdom Research Site Bradford
United Kingdom Research Site Guildford
United Kingdom Research Site Ipswich
United Kingdom Research Site London
United Kingdom Research Site Maidstone
United Kingdom Research Site Maidstone Kent
United Kingdom Research Site Newcastle Upon Tyne
United Kingdom Research Site Newcastle-upon-tyne
United Kingdom Research Site Northwood
United Kingdom Research Site Northwood Middlesex
United Kingdom Research Site Poole
United Kingdom Research Site Southampton Hampshire
United Kingdom Research Site Stockport
United Kingdom Research Site Sutton
United Kingdom Research Site Sutton Surrey
United States Research Site Abingdon Virginia
United States Research Site Alexandria Virginia
United States Research Site Alexandria Louisiana
United States Research Site Ann Arbor Michigan
United States Research Site Anniston Alabama
United States Research Site Austin Texas
United States Research Site Bay Pines Florida
United States Research Site Birmingham Alabama
United States Research Site Bismarck North Dakota
United States Research Site Casa Grande Arizona
United States Research Site Chattanooga Tennessee
United States Research Site Cincinnati Ohio
United States Research Site Coos Bay Oregon
United States Research Site Fairfield Connecticut
United States Research Site Fayetteville North Carolina
United States Research Site Fort Meyers Florida
United States Research Site Fresh Meadows New York
United States Research Site Galesburg Illinois
United States Research Site Great Falls Montana
United States Research Site Hagerstown Maryland
United States Research Site Hilton Head Island South Carolina
United States Research Site Hot Springs Arkansas
United States Research Site Knoxville Tennessee
United States Research Site Layfayette Indiana
United States Research Site Layfayette Louisiana
United States Research Site Lincoln Nebraska
United States Research Site Middletown Ohio
United States Research Site Nashville Tennessee
United States Research Site New Albany Indiana
United States Research Site New Bern North Carolina
United States Research Site Northport New York
United States Research Site Palm Springs California
United States Research Site Park Ridge Illinois
United States Research Site Port St Lucie Florida
United States Research Site Port St. Lucie Florida
United States Research Site Quincy Illinois
United States Research Site Rochester New York
United States Research Site San Diego California
United States Research Site St Louis Missouri
United States Research Site Stamford Connecticut
United States Research Site Summit New Jersey
United States Research Site Tucson Arizona
United States Research Site White River Junction Vermont
United States Research Site Ypsilanti Michigan
United States Research Site Zanesville Ohio
Vietnam Research Site Hanoi city
Vietnam Research Site Ho Chi Minh
Vietnam Research Site Ho Chi Minh city

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  Egypt,  Finland,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Latvia,  Malta,  Philippines,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression
Secondary Overall Survival Number of months from randomisation to the date of death from any cause Randomisation until data cut-off
Secondary Objective Response Rate Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:
CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Up until data cut-off
Secondary Duration of Response Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009. Up until data cut-off date of 15/11/2007
Secondary Percentage Change in Tumour Size Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100 Baseline to Week 8
Secondary Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI) Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded. Baseline through to data cut-off
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A