First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00384176
First received: October 3, 2006
Last updated: January 13, 2015
Last verified: January 2015
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression ] [ Designated as safety issue: No ]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 Outcome Measures:
- Overall Survival [ Time Frame: Randomisation until data cut-off ] [ Designated as safety issue: No ]Number of months from randomisation to the date of death from any cause
- Objective Response Rate [ Time Frame: Up until data cut-off ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 1814 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2015 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384176
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00384176
Show 180 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson | AstraZeneca |
More Information
Additional Information:
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00384176 History of Changes |
| Other Study ID Numbers: | D8480C00013, Eudract Number 2005-003440-66 |
| Study First Received: | October 3, 2006 |
| Results First Received: | March 7, 2012 |
| Last Updated: | January 13, 2015 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Austria: Federal Ministry for Health and Women Czech Republic: State Institute for Drug Control Belgium: Ministry of Social Affairs, Public Health and the Environment United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Metastatic Colorectal Cancer RECENTIN |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms |
Neoplasms by Site Rectal Diseases Cediranib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015