FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
NCT ID: NCT01418222
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2011-09-14
2013-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
5-FU
Intravenous repeating dose
FOLFOX regimen
Intravenous repeating dose
bevacizumab [Avastin]
Intravenous repeating dose
leucovorin
Intravenous repeating dose
onartuzumab [MetMAb]
Intravenous repeating dose
B
5-FU
Intravenous repeating dose
FOLFOX regimen
Intravenous repeating dose
Placebo
Intravenous repeating dose
bevacizumab [Avastin]
Intravenous repeating dose
leucovorin
Intravenous repeating dose
Interventions
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5-FU
Intravenous repeating dose
FOLFOX regimen
Intravenous repeating dose
Placebo
Intravenous repeating dose
bevacizumab [Avastin]
Intravenous repeating dose
leucovorin
Intravenous repeating dose
onartuzumab [MetMAb]
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable disease by RECIST criteria
* Adequate organ system function, as defined by protocol
Exclusion Criteria
* Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
* Previously untreated brain metastases
* History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* History of hematemesis or hemoptysis \</= 1 months prior to study enrollment
* Significant cardiovascular disease or disorder
* History of abdominal fistula or gastrointestinal perforation \</= 6 months prior to Day 1
* Positive for hepatitis B, hepatitis C or HIV infection
* Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer
18 Years
ALL
No
Sponsors
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SCRI Development Innovations, LLC
OTHER
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Almac Clinical Technologies
San Francisco, California, United States
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States
Florida Hospital Cancer Inst
Orlando, Florida, United States
Georgia Cancer Specialists - Northside
Atlanta, Georgia, United States
University of Chicago; Hematology/Oncology
Chicago, Illinois, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
Ingalls Memorial Hospital; Cancer Research Center
Harvey, Illinois, United States
Baptist Hospital East
Louisville, Kentucky, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
Saint Louis Cancer Care, LLP
Bridgeton, Missouri, United States
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City, Missouri, United States
Hem-Onc Assoc of Northern NJ
Morristown, New Jersey, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Toledo Comm. Onc. Program
Toledo, Ohio, United States
University of Oklahoma; Stephenson Oklahoma Canc Ctr
Oklahoma City, Oklahoma, United States
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States
Ctr for Cancer and Blood Disorders
Fort Worth, Texas, United States
South Texas Oncology & Hematology, P.A.
San Antonio, Texas, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Countries
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References
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Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.
Other Identifiers
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GO27827
Identifier Type: -
Identifier Source: org_study_id
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