First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)
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ClinicalTrials.gov Identifier: NCT00384176 |
Recruitment Status :
Completed
First Posted : October 5, 2006
Results First Posted : November 28, 2012
Last Update Posted : April 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: Cediranib Drug: Bevacizumab Drug: 5-fluorouracil ( in FOLFOX) Drug: Leucovorin (in FOLFOX) Drug: Oxaliplatin (in FOLFOX) | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1814 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 30, 2006 |
Actual Primary Completion Date : | November 15, 2009 |
Actual Study Completion Date : | August 19, 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Bevacizumab + FOLFOX
|
Drug: Bevacizumab
intravenous infusion
Other Name: Avastin® Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion
Other Name: 5-FU Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) intravenous infusion
Other Name: Eloxatin® |
Experimental: 2
Cediranib + FOLFOX
|
Drug: Cediranib
oral tablet once daily
Other Names:
Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion
Other Name: 5-FU Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) intravenous infusion
Other Name: Eloxatin® |
- 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.
- Overall Survival [ Time Frame: Randomisation until data cut-off ]Number of months from randomisation to the date of death from any cause
- 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.
- 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.
- 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
- 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.

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Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384176

Study Director: | Jane Robertson | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00384176 |
Other Study ID Numbers: |
D8480C00013 Eudract Number 2005-003440-66 |
First Posted: | October 5, 2006 Key Record Dates |
Results First Posted: | November 28, 2012 |
Last Update Posted: | April 14, 2017 |
Last Verified: | April 2017 |
Metastatic Colorectal Cancer RECENTIN |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Bevacizumab Fluorouracil Oxaliplatin |
Cediranib Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antidotes Protective Agents |