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OpenTrials
Completed

NCT Number: NCT00384176

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Research Site, Armidale, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cediranib

Drug

oral tablet once daily

Other names: RECENTIN™, AZD2171

Bevacizumab

Drug

intravenous infusion

Other names: Avastin®

5-fluorouracil ( in FOLFOX)

Drug

intravenous infusion

Other names: 5-FU

Leucovorin (in FOLFOX)

Drug

intravenous infusion

Oxaliplatin (in FOLFOX)

Drug

intravenous infusion

Other names: Eloxatin®

Primary outcomes

  1. Progression Free Survival

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

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: Randomisation until data cut-off

    Number of months from randomisation to the date of death from any cause

  2. Objective Response Rate

    Time frame: Up until data cut-off

    Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below:

    CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.

  3. Duration of Response

    Time frame: Up until data cut-off date of 15/11/2007

    Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.

  4. Percentage Change in Tumour Size

    Time frame: Baseline to Week 8

    Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)*100

  5. 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

    Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: HORIZON III

Important dates

Study start
2006
Primary completion
2009
Study completion
2015
First posted
Oct 5, 2006
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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