OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
NCT ID: NCT00577031
Last Updated: 2015-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
205 participants
INTERVENTIONAL
2008-02-29
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
bevacizumab [Avastin]
7.5mg iv on day 1 of each 3 week cycle
Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle
Xeloda
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Interventions
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bevacizumab [Avastin]
7.5mg iv on day 1 of each 3 week cycle
Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle
Xeloda
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Eligibility Criteria
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Inclusion Criteria
* locally advanced or metastatic colorectal cancer;
* no previous treatment with chemotherapy for metastatic disease;
* at least one measurable lesion.
Exclusion Criteria
* untreated brain metastases or primary brain tumors;
* clinically significant cardiovascular disease;
* chronic daily treatment with high dose aspirin (\>325 mg/day);
* other co-existing malignancies or malignancies diagnosed within last 5 years.
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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Bologna, , Italy
Brescia, , Italy
Cagliari, , Italy
Cagliari, , Italy
Caserta, , Italy
Catanzaro, , Italy
Cefalù, , Italy
Fano, , Italy
Florence, , Italy
Frattaminore, , Italy
Grosseto, , Italy
Ivrea, , Italy
Latisana, , Italy
Lecce, , Italy
Legnago, , Italy
Legnano, , Italy
Macerata, , Italy
Napoli, , Italy
Negrar, , Italy
Orbassano, , Italy
Padua, , Italy
Palermo, , Italy
Palermo, , Italy
Pavia, , Italy
Reggio Calabria, , Italy
Reggio Emilia, , Italy
Rionero in Vulture, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Salerno, , Italy
San Giovanni Rotondo, , Italy
Sondrio, , Italy
Taormina, , Italy
Torino, , Italy
Torino, , Italy
Verbania, , Italy
Countries
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References
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Antonuzzo L, Giommoni E, Pastorelli D, Latiano T, Pavese I, Azzarello D, Aieta M, Pastina I, Di Fabio F, Bertolini A, Corsi DC, Mogavero S, Angelini V, Pazzagli M, Di Costanzo F. Bevacizumab plus XELOX as first-line treatment of metastatic colorectal cancer: The OBELIX study. World J Gastroenterol. 2015 Jun 21;21(23):7281-8. doi: 10.3748/wjg.v21.i23.7281.
Other Identifiers
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ML21380
Identifier Type: -
Identifier Source: org_study_id
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