Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments cediranib, bevacizumab, 5-fluorouracil ( in folfox), leucovorin (in folfox), oxaliplatin (in folfox)
Phase phase 2/phase 3
Target VEGF
Sponsor AstraZeneca
Start date August 2006
End date November 2009
Trial size 1814 participants
Trial identifier NCT00384176, D8480C00013, Eudract Number 2005-003440-66

Summary

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Bevacizumab + FOLFOX
bevacizumab Avastin®
intravenous infusion
5-fluorouracil ( in folfox) 5-FU
intravenous infusion
leucovorin (in folfox)
intravenous infusion
oxaliplatin (in folfox) Eloxatin®
intravenous infusion
(Experimental)
Cediranib + FOLFOX
cediranib RECENTIN™
oral tablet once daily
5-fluorouracil ( in folfox) 5-FU
intravenous infusion
leucovorin (in folfox)
intravenous infusion
oxaliplatin (in folfox) Eloxatin®
intravenous infusion

Primary Outcomes

Measure
Progression Free Survival
time frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Secondary Outcomes

Measure
Overall Survival
time frame: Randomisation until data cut-off
Objective Response Rate
time frame: Up until data cut-off
Duration of Response
time frame: Up until data cut-off date of 15/11/2007
Percentage Change in Tumour Size
time frame: Baseline to Week 8
Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)
time frame: Baseline through to data cut-off

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical Diagnosis of colon or rectal cancer - No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry. Exclusion Criteria: - Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib. - Poorly controlled hypertension

Additional Information

Official title A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.