A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00069095
Last Updated: 2016-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2035 participants
INTERVENTIONAL
2003-07-31
2009-04-30
Brief Summary
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Detailed Description
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The study consisted of 3 phases, a Primary Study Treatment Phase, a Post-Study Treatment Phase, and a Follow-Up Phase.
Primary Study Treatment Phase
Patients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part of the study) of treatment during the Primary Study Treatment Phase (48 weeks).
Post-Study Treatment Phase
Patients who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Patients who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the patient withdrew consent.
Follow-up Phase
Patients who terminated study treatment during the primary or post-study treatment phase were followed until disease progression or death.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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XELOX (oxaliplatin+capecitabine)
Patients in the 2-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.
Placebo for bevacizumab 7.5 mg/kg
Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
XELOX (oxaliplatin+capecitabine) + bevacizumab
Patients in the 4-arm part of the study received oxaliplatin 130 mg/m\^2 intravenously (iv) on Day 1 of every 3 week cycle + capecitabine 1000 mg/m\^2 orally twice a day for the first 2 weeks of every 3 week cycle + bevacizumab 7.5 mg/kg iv on Day 1 of every 3 week cycle.
Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.
Bevacizumab 7.5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil)
Patients in the 2-arm part of the study received oxaliplatin 85 mg/m\^2 intravenously (iv) + leucovorin 200 mg/m\^2 iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle. Patients in the 4-arm part of the study received the same treatments plus placebo for bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle.
Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.
Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.
Fluorouracil 400 mg/m^2
Placebo for bevacizumab 5 mg/kg
Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
FOLFOX-4 (oxaliplatin+leucovorin+fluorouracil) + bevacizumab
Patients in the 4-arm part of the study received oxaliplatin 85 mg/m\^2 intravenously (iv) + leucovorin 200 mg/m\^2 iv + bevacizumab 5 mg/kg iv on Day 1 of every 2 week cycle + fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2 week cycle.
Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.
Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.
Fluorouracil 400 mg/m^2
Bevacizumab 5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
Interventions
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Oxaliplatin 130 mg/m^2
Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.
Capecitabine 1000 mg/m^2
Capecitabine was taken within 30 min after the end of breakfast and dinner.
Bevacizumab 7.5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
Placebo for bevacizumab 7.5 mg/kg
Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Oxaliplatin 85 mg/m^2
Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.
Leucovorin 200 mg/m^2
Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.
Fluorouracil 400 mg/m^2
Bevacizumab 5 mg/kg
Bevacizumab was administered in a 30 to 90 min infusion.
Placebo for bevacizumab 5 mg/kg
Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic colorectal cancer.
* ≥ 1 target lesion.
Exclusion Criteria
* Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
* Progressive disease during or within 6 months of completion of previous adjuvant therapy.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Berkeley, California, United States
Fountain Valley, California, United States
Fullerton, California, United States
Gilroy, California, United States
Greenbrae, California, United States
Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
San Diego, California, United States
Norwich, Connecticut, United States
Waterbury, Connecticut, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Peoria, Illinois, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Scarborough, Maine, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Saint Louis Park, Minnesota, United States
Las Vegas, Nevada, United States
East Orange, New Jersey, United States
Hamilton, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Farmington, New Mexico, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Sayre, Pennsylvania, United States
Upland, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Burlington, Vermont, United States
Richmond, Virginia, United States
Adelaide, , Australia
Box Hill, , Australia
Brisbane, , Australia
Camperdown, , Australia
Fitzroy, , Australia
Footscray, , Australia
Kurralta Park, , Australia
Malvern, , Australia
Melbourne, , Australia
Melbourne, , Australia
Perth, , Australia
Port Macquarie, , Australia
St Leonards, , Australia
Sydney, , Australia
Sydney, , Australia
Vienna, , Austria
Wels, , Austria
Jaú, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
North Vancouver, British Columbia, Canada
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Beijing, , China
Beijing, , China
Guangdong, , China
Guangzhou, , China
Jiangsu, , China
Jiangxi, , China
Shandong, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Wuhan, , China
Brno, , Czechia
Chomutov, , Czechia
Hradec Králové, , Czechia
Ostrava, , Czechia
Copenhagen, , Denmark
Herlev, , Denmark
Odense, , Denmark
Helsinki, , Finland
Tampere, , Finland
Turku, , Finland
Besançon, , France
Bobigny, , France
Boulogne-Billancourt, , France
Brest, , France
Chambray-lès-Tours, , France
Colmar, , France
Dijon, , France
Grenoble, , France
Lyon, , France
Metz, , France
Nice, , France
Nice, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Rouen, , France
Saint-Herblain, , France
Saint-Herblain, , France
Toulouse, , France
Bochum, , Germany
Halle, , Germany
Hanover, , Germany
Herne, , Germany
Leipzig, , Germany
Mainz, , Germany
Mannheim, , Germany
Regensburg, , Germany
Stralsund, , Germany
Trier, , Germany
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Kecskemét, , Hungary
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Galway, , Ireland
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Ancona, , Italy
Genova, , Italy
Modena, , Italy
Padua, , Italy
Parma, , Italy
Pavia, , Italy
Reggio Emilia, , Italy
Sassari, , Italy
Mexico City, , Mexico
Christchurch, , New Zealand
Bergen, , Norway
Oslo, , Norway
Tromsø, , Norway
Panama City, , Panama
Beja, , Portugal
Lisbon, , Portugal
San Juan, , Puerto Rico
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Cape Town, , South Africa
Pretoria, , South Africa
Sandton, , South Africa
Seoul, , South Korea
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Granada, , Spain
Leganés, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Gävle, , Sweden
Karlstad, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Västerås, , Sweden
Bern, , Switzerland
Geneva, , Switzerland
Kueishan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Khon Kaen, , Thailand
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Aberdeen, , United Kingdom
Birmingham, , United Kingdom
Cardiff, , United Kingdom
Derby, , United Kingdom
Glasgow, , United Kingdom
Guildford, , United Kingdom
Hull, , United Kingdom
London, , United Kingdom
Maidstone, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Northwood, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Salisbury, , United Kingdom
Southampton, , United Kingdom
Sutton, , United Kingdom
Taunton, , United Kingdom
Countries
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Other Identifiers
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NO16966
Identifier Type: -
Identifier Source: org_study_id
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