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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 SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia