Second line ColoRectal Cancer therapy in combination with combination of FOL- Folinic acid(leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX) - HORIZON I
Study identifier:D8480C00041
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Study to Compare the Efficacy of AZD2171 in Combination with 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination with FOLFOX in the Second-line Treatment of Patients with Metastatic Colorectal Cancer
Medical condition
Colorectal Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD2171, 5-fluorouracil, Leucovorin, Oxaliplatin, Bevacizumab
Sex
All
Actual Enrollment
215
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jan 2006
Primary Completion Date: 01 Nov 2007
Study Completion Date: 01 Oct 2009
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Bevacizumab + FOLFOX | Drug: 5-fluorouracil intravenous infusion Other Name: 5-FU Drug: Leucovorin intravenous infusion Drug: Oxaliplatin intravenous infusion Other Name: Eloxatin® Drug: Bevacizumab intravenous infusion Other Name: Avastin® |
| Experimental: 2 AZD2171 + FOLFOX | Drug: AZD2171 oral tablet Other Name: cediranib Other Name: RECENTIN™ Drug: 5-fluorouracil intravenous infusion Other Name: 5-FU Drug: Leucovorin intravenous infusion Drug: Oxaliplatin intravenous infusion Other Name: Eloxatin® |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
