MedTrace Logo

Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer

NCT00399035 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1254

Last updated 2016-12-28

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.

Conditions

Interventions

DRUG

Cediranib

oral tablet

DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

intravenous infusion

DRUG

XELOX (Capecitabine and Oxaliplatin)

intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)

DRUG

Cediranib Placebo

oral tablet

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-03-31
Completion
2016-08-31

Countries

  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • China
  • Czechia
  • Germany
  • Hungary
  • India
  • Philippines
  • Poland
  • South Korea
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399035 on ClinicalTrials.gov