First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Bevacizumab; Drug: Cediranib; Drug: 5-fluorouracil ( in FOLFOX); Drug: Leucovorin (in FOLFOX); Drug: Oxaliplatin (in FOLFOX)

• Registration Number: NCT00384176
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-05
• Primary Completion: 2009-11-15
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-04-06
• Disposition First Posted: 2011-04-12
• Results First Submitted: 2012-03-07
• Results First Submitted QC: 2012-10-29
• Results First Posted: 2012-11-28
• Study Completion: 2015-08-19
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1814

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	5-fluorouracil ( in FOLFOX)	Cediranib + FOLFOX
2	Leucovorin (in FOLFOX)	Cediranib + FOLFOX
1	5-fluorouracil ( in FOLFOX)	Bevacizumab + FOLFOX
1	Leucovorin (in FOLFOX)	Bevacizumab + FOLFOX
1	Oxaliplatin (in FOLFOX)	Bevacizumab + FOLFOX
2	Oxaliplatin (in FOLFOX)	Cediranib + FOLFOX
1	Bevacizumab	Bevacizumab + FOLFOX
2	Cediranib	Cediranib + FOLFOX

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	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 Outcome Measures

Name	Time	Method
Overall Survival	Randomisation until data cut-off	Number of months from randomisation to the date of death from any cause
Objective Response Rate	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	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	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)	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.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam