First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX - Full Text View

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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Oxaliplatin Bevacizumab

U.S. FDA Resources

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: RECENTIN™ AZD2171 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 (Adult, Senior)
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

Show 180 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Jane Robertson	AstraZeneca

More Information

Additional Information:

CSR-D8480C00013.pdf This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.


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:	June 18, 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab Oxaliplatin Cediranib	Fluorouracil Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Protein Kinase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2016

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)