Colorectal Cancer Clinical Trial
— HORIZON IIIOfficial title:
A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer
| Verified date | April 2017 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
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,
| 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 |
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