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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Outcome Time Frame:

Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression

Safety Issue:

No

Principal Investigator

Jane Robertson

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D8480C00013

NCT ID:

NCT00384176

Start Date:

August 2006

Completion Date:

August 2013

Related Keywords:

  • Colorectal Cancer
  • Metastatic Colorectal Cancer
  • RECENTIN
  • Colorectal Neoplasms

Name

Location
Research Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Bentonville, Arkansas  
Research Site Anaheim, California  
Research Site Danbury, Connecticut  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Battle Kreek, Michigan  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Belleville, New Jersey  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Charleston, South Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Bennington, Vermont  
Research Site Abington, Virginia