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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
Inclusion Criteria:
- Clinical diagnosis of colon or rectal cancer,
- Received prior systemic therapy for cancer,
- Cancer must have progressed during or after first treatment
Exclusion Criteria:
- Prior treatment with a VEGF inhibitor,
- Poorly controlled hypertension
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
Number of months from randomisation to the earlier date of objective progression or death
Outcome Time Frame:
Randomisation to data cut-off date of November 2007
Safety Issue:
No
Principal Investigator
Jane Robertson
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study ID:
D8480C00041
NCT ID:
NCT00278889
Start Date:
January 2006
Completion Date:
October 2009
Related Keywords:
- Colorectal Cancer
- Colorectal Cancer
- phase II
- metastatic colorectal cancer
- AZD2171
- RECENTIN
- Colorectal Neoplasms
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