First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
NCT ID: NCT00384176
Last Updated: 2017-04-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
1814 participants
INTERVENTIONAL
2006-08-30
2015-08-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
NCT00278889
A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer
NCT00192075
A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
NCT00615056
Combination Chemotherapy and Bevacizumab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
NCT00719797
Efficacy of FOLFOX+Bevacizumab in Combination With Irinotecan in the Treatment of Metastatic Colorectal Cancer
NCT01321957
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Bevacizumab + FOLFOX
Bevacizumab
intravenous infusion
5-fluorouracil ( in FOLFOX)
intravenous infusion
Leucovorin (in FOLFOX)
intravenous infusion
Oxaliplatin (in FOLFOX)
intravenous infusion
2
Cediranib + FOLFOX
Cediranib
oral tablet once daily
5-fluorouracil ( in FOLFOX)
intravenous infusion
Leucovorin (in FOLFOX)
intravenous infusion
Oxaliplatin (in FOLFOX)
intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cediranib
oral tablet once daily
Bevacizumab
intravenous infusion
5-fluorouracil ( in FOLFOX)
intravenous infusion
Leucovorin (in FOLFOX)
intravenous infusion
Oxaliplatin (in FOLFOX)
intravenous infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Poorly controlled hypertension
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jane Robertson
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Casa Grande, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Palm Springs, California, United States
Research Site
San Diego, California, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Stamford, Connecticut, United States
Research Site
Bay Pines, Florida, United States
Research Site
Fort Meyers, Florida, United States
Research Site
Port Saint Lucie, Florida, United States
Research Site
Galesburg, Illinois, United States
Research Site
Park Ridge, Illinois, United States
Research Site
Quincy, Illinois, United States
Research Site
Layfayette, Indiana, United States
Research Site
New Albany, Indiana, United States
Research Site
Alexandria, Louisiana, United States
Research Site
Layfayette, Louisiana, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Great Falls, Montana, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Summit, New Jersey, United States
Research Site
Fresh Meadows, New York, United States
Research Site
Northport, New York, United States
Research Site
Rochester, New York, United States
Research Site
Fayetteville, North Carolina, United States
Research Site
New Bern, North Carolina, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Middletown, Ohio, United States
Research Site
Zanesville, Ohio, United States
Research Site
Coos Bay, Oregon, United States
Research Site
Hilton Head Island, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
White River Junction, Vermont, United States
Research Site
Abingdon, Virginia, United States
Research Site
Alexandria, Virginia, United States
Research Site
Armidale, New South Wales, Australia
Research Site
Coffs Harbour, New South Wales, Australia
Research Site
Darlinghurst, New South Wales, Australia
Research Site
Hornsby, New South Wales, Australia
Research Site
Kogarah, New South Wales, Australia
Research Site
Port Macquarie, New South Wales, Australia
Research Site
Randwick, New South Wales, Australia
Research Site
St Leonards, New South Wales, Australia
Research Site
Tamworth, New South Wales, Australia
Research Site
Waratah, New South Wales, Australia
Research Site
South Brisbane, Queensland, Australia
Research Site
Ashford, South Australia, Australia
Research Site
Bedford Park, South Australia, Australia
Research Site
Woodville South, South Australia, Australia
Research Site
Hobart, Tasmania, Australia
Research Site
Epping, Victoria, Australia
Research Site
Ashford, , 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
Darlinghurst, , Australia
Research Site
East Melbourne, , Australia
Research Site
Epping, , Australia
Research Site
Herston, , Australia
Research Site
Hobart, , Australia
Research Site
Hornsby, , Australia
Research Site
Kogarah, , Australia
Research Site
Lismore, , Australia
Research Site
Malvern, , Australia
Research Site
Nedlands, , Australia
Research Site
Port Macquarie, , Australia
Research Site
Randwick, , Australia
Research Site
South Brisbane, , Australia
Research Site
St Leonards, , Australia
Research Site
Tamworth, , Australia
Research Site
Waratah, , Australia
Research Site
Wodonga, , Australia
Research Site
Woodville South, , Australia
Research Site
Kundratstrasse 3, Vienna, Austria
Research Site
Innsbruck, , Austria
Research Site
Kundratstrasse 3, , Austria
Research Site
Salzburg, , Austria
Research Site
Vienna, , Austria
Research Site
Wels, , Austria
Research Site
Zams, , Austria
Research Site
Bonheiden, Belgium, Belgium
Research Site
Brussels (woluwe-st-lambert), Belgium, Belgium
Research Site
Edegem, Belgium, Belgium
Research Site
Ghent, Belgium, Belgium
Research Site
Kortrijk, Belgium, Belgium
Research Site
Leuven, Belgium, Belgium
Research Site
Roeselare, Belgium, Belgium
Research Site
Bonheiden, , Belgium
Research Site
Bruges, , Belgium
Research Site
Brussels (Woluwé-St-Lambert), , Belgium
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Kortrijk, , Belgium
Research Site
Leuven, , Belgium
Research Site
Roeselare, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Sydney, Nova Scotia, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
St. Catharines, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
York, Ontario, Canada
Research Site
Lévis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Montreal, , Canada
Research Site
Brno, , Czechia
Research Site
Chomutov, , Czechia
Research Site
Kutná Hora, , Czechia
Research Site
Nová Ves pod Pleší, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Tábor, , Czechia
Research Site
Alexandria, , Egypt
Research Site
Cairo, , Egypt
Research Site
Helsinki, , Finland
Research Site
Tampere, , Finland
Research Site
Turku, , Finland
Research Site
Vaasa, , Finland
Research Site
Boulogne, , France
Research Site
La Roche S YON, , France
Research Site
Marseille, , France
Research Site
Nantes, , France
Research Site
Paris, , France
Research Site
Saint-Grégoire, , France
Research Site
Dresden, , Germany
Research Site
Essen, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Halle, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
München, , Germany
Research Site
Neu-Isenburg, , Germany
Research Site
Tübingen, , Germany
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Tatabánya, , Hungary
Research Site
Bhopal, Madhya Pradesh, India
Research Site
Pune, Maharashtra, India
Research Site
Jaipur, Rajasthan, India
Research Site
Varanasi, Uttar Prad, India
Research Site
Kolkata, West Bengal, India
Research Site
Bangalore, , India
Research Site
Bhopal, , India
Research Site
Chennai, , India
Research Site
Hyderabad, , India
Research Site
Jaipur, , India
Research Site
Kolkata, , India
Research Site
Mumbai, , India
Research Site
Pune, , India
Research Site
Sheikhpura, , India
Research Site
Holon, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Tel Litwinsky, , Israel
Research Site
Tiberias, , Israel
Research Site
Tzrifin, , Israel
Research Site
Genova, GE, Italy
Research Site
Rozzano, MI, Italy
Research Site
Roma, Roma, Italy
Research Site
Ancona, , Italy
Research Site
Genova, , Italy
Research Site
Napoli, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Riga, , Latvia
Research Site
Floriana, , Malta
Research Site
Valletta, , Malta
Research Site
Cebu City, , Philippines
Research Site
Davao City, , Philippines
Research Site
Molo, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Bytom, , Poland
Research Site
Elblag, , Poland
Research Site
Gdynia, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Rybnik, , Poland
Research Site
Warsaw, , Poland
Research Site
Barnaul, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Omsk, , Russia
Research Site
Tomsk, , Russia
Research Site
Tyumen, , Russia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Lyttelton Manor, South Africa, South Africa
Research Site
Cape Town, , South Africa
Research Site
Polokwane, , South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Granollers, Catalonia, Spain
Research Site
Hospitalet de Llobregat(barcel, Catalonia, Spain
Research Site
Terrassa(barcelona), Catalonia, Spain
Research Site
A Coruña, Galicia, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Oviedo, Principality of Asturias, Spain
Research Site
Valencia, Valencia, Spain
Research Site
A Coruña, , Spain
Research Site
Córdoba, , Spain
Research Site
Granollers, , Spain
Research Site
Hospitalet de Llobregat(Barcel, , Spain
Research Site
Madrid, , Spain
Research Site
Manresa, , Spain
Research Site
Oviedo, , Spain
Research Site
Valencia, , Spain
Research Site
Zaragoza, , Spain
Research Site
Taoyuan District, Taiwan, Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Nakhonratchasima, Naimuang, Thailand
Research Site
Chiang Mai, Thailand, Thailand
Research Site
Songkhla, Thailand, Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Rachathewi, , Thailand
Research Site
Songkhla, , Thailand
Research Site
Istanbul, Goztepe, Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
Research Site
Cherkassy, , Ukraine
Research Site
Chernihiv, , Ukraine
Research Site
Chernivtsi, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kharkiv, , Ukraine
Research Site
Kherson, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Luhansk, , Ukraine
Research Site
Lviv, , Ukraine
Research Site
Poltava, , Ukraine
Research Site
Simferopol, , Ukraine
Research Site
Sumy, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Southampton, Hampshire, United Kingdom
Research Site
Maidstone, Kent, United Kingdom
Research Site
Northwood, Middlesex, United Kingdom
Research Site
Sutton, Surrey, 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
Newcastle upon Tyne, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Poole, , United Kingdom
Research Site
Stockport, , United Kingdom
Research Site
Sutton, , United Kingdom
Research Site
Hanoi, Vietnam, Vietnam
Research Site
Ho Chi Minh City, Vietnam, Vietnam
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.
Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.
Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Eudract Number 2005-003440-66
Identifier Type: -
Identifier Source: secondary_id
D8480C00013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.