A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin
NCT ID: NCT01077739
Last Updated: 2014-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2009-07-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Avastin (bevacizumab) + standard of care
fluorouracil (5FU)
standard FOLFOX regimen
leucovorin
standard FOLFOX regimen
bevacizumab [Avastin]
7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
capecitabine [Xeloda]
standard XELOX regimen
oxaliplatin
standard XELOX or FOLFOX regimen
Interventions
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fluorouracil (5FU)
standard FOLFOX regimen
leucovorin
standard FOLFOX regimen
bevacizumab [Avastin]
7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
capecitabine [Xeloda]
standard XELOX regimen
oxaliplatin
standard XELOX or FOLFOX regimen
Eligibility Criteria
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Inclusion Criteria
* metastatic colorectal cancer
* at least 1 measurable lesion according to RECIST v. 1.1
* patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
* disease progression \</= 8 weeks after last dose of Avastin
* ECOG \</=2
* No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin
Exclusion Criteria
* clinically significant cardiovascular disease
* CNS disease except for treated brain metastasis
* history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
* major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
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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Aalst, , Belgium
Arlon, , Belgium
Assebroek, , Belgium
Aye, , Belgium
Bonheiden, , Belgium
Brasschaat, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Dendermonde, , Belgium
Edegem, , Belgium
Genk, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Mechelen, , Belgium
Merksem, , Belgium
Mont-godinne, , Belgium
Montigny-le-Tilleul, , Belgium
Namur, , Belgium
Ostend, , Belgium
Sint-Niklaas, , Belgium
Tournai, , Belgium
Turnhout, , Belgium
Verviers, , Belgium
Wilrijk, , Belgium
Countries
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Other Identifiers
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2009-012090-36
Identifier Type: -
Identifier Source: secondary_id
ML22519
Identifier Type: -
Identifier Source: org_study_id
NCT01069679
Identifier Type: -
Identifier Source: nct_alias