Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00561470

Recruitment Status : Completed

First Posted : November 21, 2007

Results First Posted : September 28, 2012

Last Update Posted : September 28, 2012

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Regeneron Pharmaceuticals

NSABP Foundation Inc

Information provided by (Responsible Party):

Sanofi

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Conditions	Colorectal Neoplasms Neoplasm Metastasis
Interventions	Drug: Placebo Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Enrollment	1226

Participant Flow

Recruitment Details	Between 19 November 2007 and 16 March 2010, 614 participants were randomized to the placebo arm and 612 participants were randomized to the aflibercept arm.
Pre-assignment Details


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Period Title: Overall Study
Started	614	612
TREATED	609	607
SAFETY POPULATION	605 ^[1]	611 ^[2]
ONGOING TREATMENT	11 ^[3]	14 ^[3]
Completed	0 ^[4]	0 ^[4]
Not Completed	614	612
Reason Not Completed
Adverse Event	74	163
Disease progression	437	305
poor compliance to protocol	4	4
Lost to Follow-up	2	0
Physician Decision	21	20
Consent Withdrawn	2	6
Subject request	43	77
Metastatic surgery	10	12
Unauthorized procedure	3	1
Randomized but not treated	5	5
Missed visit window	1	4
Planning surgery	1	1
Ongoing Treatment	11	14
[1] Treated participants excluding 4 who received at least 1 dose of Aflibercept [2] Treated participants including 4 from Placebo/FOLFIRI who received at least 1 dose of Aflibercept [3] Participants continuing treatment on the cutoff date of the final analysis [4] Participants met treatment discontinuation criteria or were ongoing treatment on the cutoff date

Baseline Characteristics

Arm/Group Title		Placebo/Folfiri	Aflibercept/Folfiri	Total
Arm/Group Description		Participants with Metastatic Colore...	Participants with Metastatic Colore...	Total of all reporting groups
Arm/Group Description		Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)	Total of all reporting groups
Overall Number of Baseline Participants		614	612	1226
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	614 participants	612 participants	1226 participants
		60.2 (10.8)	59.5 (10.5)	59.8 (10.7)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
<65 years		376	407	783
>=65 but <75 years		199	172	371
>=75 years		39	33	72
Sex/Gender, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
Male		353	365	718
Female		261	247	508
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
Caucasian/White		523	548	1071
Black		27	16	43
Asian/Oriental		51	35	86
Other		13	13	26
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
ARGENTINA		4	2	6
AUSTRALIA		42	54	96
AUSTRIA		3	4	7
BELGIUM		37	45	82
BRAZIL		21	27	48
CHILE		31	33	64
CZECH REPUBLIC		30	47	77
DENMARK		9	6	15
ESTONIA		7	3	10
FRANCE		1	1	2
GERMANY		23	12	35
GREECE		9	10	19
ITALY		26	23	49
KOREA, REPUBLIC OF		39	26	65
NETHERLANDS		20	14	34
NEW ZEALAND		13	7	20
NORWAY		14	19	33
POLAND		24	32	56
PUERTO RICO		4	2	6
ROMANIA		16	16	32
RUSSIAN FEDERATION		35	40	75
SOUTH AFRICA		36	31	67
SPAIN		27	28	55
SWEDEN		10	4	14
TURKEY		4	2	6
UKRAINE		11	11	22
UNITED KINGDOM		47	52	99
UNITED STATES		71	61	132
Eastern Cooperative Oncology Group (ECOG) performance status score ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
Participants with ECOG Score = 0		350	349	699
Participants with ECOG Score = 1		250	250	500
Participants with ECOG Score = 2		14	13	27
		[1] Measure Description: The ECOG score assesses how the disease affects a participant's daily living abilities. It ranges from 0-5, with 0 being the best and 5 being the worst outcome. "0" reflects a fully active participant, able to carry on all pre-disease performance without restriction. "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. "2" reflects an ambulatory participant, who is up and about more than 50% of waking hours, and capable of all self-care but unable to carry out any work activities.
Prior Bevacizumab ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	614 participants	612 participants	1226 participants
Yes		187	186	373
No		427	426	853
		[1] Measure Description: Number of participants randomized in the prior bevacizumab stratum as per the interactive voice response system (IVRS).

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall Survival was the time interval from the date of randomization ...
Description	Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
Time Frame	From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized.


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description:	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description:	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Overall Number of Participants Analyzed	614	612
Overall Number of Units Analyzed Type of Units Analyzed: Events (Death)	460	403
Median (Inter-Quartile Range) Unit of Measure: months
	12.06 (6.83 to 21.03)	13.50 (7.62 to 25.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo/FOLFIRI, Aflibercept/FOLFIRI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0032
	Comments	Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.
	Method	Stratified Log-Rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Stratified Hazard Ratio
	Estimated Value	0.817
	Confidence Interval	(2-Sided) 95.34% 0.713 to 0.937
	Estimation Comments	Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.

2.Secondary Outcome


Title	Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
Description	PFS was the time interval from the date of randomization to the date o...
Description	PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.
Time Frame	From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population included all participants who gave informed consent and were randomized.


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description:	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description:	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Overall Number of Participants Analyzed	614	612
Overall Number of Units Analyzed Type of Units Analyzed: First PFS Events	454	393
Median (Inter-Quartile Range) Unit of Measure: months
	4.67 (2.60 to 9.10)	6.90 (3.84 to 10.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo/FOLFIRI, Aflibercept/FOLFIRI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.00007
	Comments	Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS
	Method	Stratified Log-Rank test
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Stratified Hazard ratio
	Estimated Value	0.758
	Confidence Interval	(2-Sided) 99.99% 0.578 to 0.995
	Estimation Comments	Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.

3.Secondary Outcome


Title	Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
Description	The overall ORR was the percentage of evaluable participants who achie...
Description	The overall ORR was the percentage of evaluable participants who achieved complete response [CR] or partial response [PR] according to RECIST criteria version 1.0. CR reflected the disappearance of all tumor lesions (with no new tumors) PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.
Time Frame	From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)

Outcome Measure Data

Analysis Population Description

The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description:	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description:	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Overall Number of Participants Analyzed	530	531
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	11.1 (8.5 to 13.8)	19.8 (16.4 to 23.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo/FOLFIRI, Aflibercept/FOLFIRI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Stratified Cochran-Mantel-Haenszel
	Comments	Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.

4.Secondary Outcome


Title	Number of Participants With Adverse Events (AE)
Description	All AEs regardless of seriousness or relationship to study treatment, ...
Description	All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
Time Frame	From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

Outcome Measure Data

Analysis Population Description

The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description:	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description:	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
Overall Number of Participants Analyzed	605	611
Measure Type: Number Unit of Measure: participants
Treatment-Emergent Adverse Event (TEAE)	592	606
Serious TEAE	198	294
TEAE leading to Death	29	37
TEAE causing permanent treatment discontinuation	73	164

5.Secondary Outcome


Title	Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay
Description	Serum samples for immunogenicity assessment were analyzed using a brid...
Description	Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.
Time Frame	Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

Outcome Measure Data

Analysis Population Description

Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.


Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description:	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description:	Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)	Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Overall Number of Participants Analyzed	526	521
Measure Type: Number Unit of Measure: participants
At least one positive sample in the ADA assay	18	8
At least one positive sample in the NAb assay	2	1

Adverse Events

Time Frame	From treatment initiation to 7 February, 2011
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Placebo/FOLFIRI	Aflibercept/FOLFIRI
Arm/Group Description	Participants with Metastatic Colore...	Participants with Metastatic Colore...
Arm/Group Description	Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks	Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
All-Cause Mortality
	Placebo/FOLFIRI	Aflibercept/FOLFIRI
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Placebo/FOLFIRI	Aflibercept/FOLFIRI
	Affected / at Risk (%)	Affected / at Risk (%)
Total	198/605 (32.73%)	294/611 (48.12%)
Blood and lymphatic system disorders
Neutropenia ^* 1	4/605 (0.66%)	11/611 (1.80%)
Thrombocytopenia ^* 1	3/605 (0.50%)	2/611 (0.33%)
Anaemia ^* 1	3/605 (0.50%)	7/611 (1.15%)
Febrile neutropenia ^* 1	6/605 (0.99%)	19/611 (3.11%)
Coagulopathy ^* 1	0/605 (0.00%)	2/611 (0.33%)
Pancytopenia ^* 1	0/605 (0.00%)	2/611 (0.33%)
Thrombotic microangiopathy ^* 1	0/605 (0.00%)	1/611 (0.16%)
Cardiac disorders
Angina pectoris ^* 1	0/605 (0.00%)	1/611 (0.16%)
Atrial fibrillation ^* 1	2/605 (0.33%)	3/611 (0.49%)
Sinus bradycardia ^* 1	0/605 (0.00%)	1/611 (0.16%)
Acute myocardial infarction ^* 1	0/605 (0.00%)	2/611 (0.33%)
Myocardial ischaemia ^* 1	1/605 (0.17%)	0/611 (0.00%)
Cardiac failure congestive ^* 1	0/605 (0.00%)	1/611 (0.16%)
Intracardiac thrombus ^* 1	0/605 (0.00%)	1/611 (0.16%)
Myocardial infarction ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pericarditis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Endocrine disorders
Hypercalcaemia of malignancy ^* 1	1/605 (0.17%)	0/611 (0.00%)
Eye disorders
Periorbital oedema ^* 1	0/605 (0.00%)	1/611 (0.16%)
Gastrointestinal disorders
Diarrhoea ^* 1	14/605 (2.31%)	44/611 (7.20%)
Nausea ^* 1	3/605 (0.50%)	4/611 (0.65%)
Stomatitis ^* 1	0/605 (0.00%)	8/611 (1.31%)
Vomiting ^* 1	7/605 (1.16%)	10/611 (1.64%)
Abdominal pain ^* 1	7/605 (1.16%)	12/611 (1.96%)
Constipation ^* 1	4/605 (0.66%)	6/611 (0.98%)
Abdominal pain upper ^* 1	3/605 (0.50%)	4/611 (0.65%)
Haemorrhoids ^* 1	0/605 (0.00%)	2/611 (0.33%)
Rectal haemorrhage ^* 1	4/605 (0.66%)	6/611 (0.98%)
Aphthous stomatitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Proctalgia ^* 1	0/605 (0.00%)	3/611 (0.49%)
Ascites ^* 1	4/605 (0.66%)	3/611 (0.49%)
Gastrooesophageal reflux disease ^* 1	0/605 (0.00%)	1/611 (0.16%)
Intestinal obstruction ^* 1	11/605 (1.82%)	10/611 (1.64%)
Abdominal pain lower ^* 1	1/605 (0.17%)	1/611 (0.16%)
Gastritis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Enteritis ^* 1	1/605 (0.17%)	2/611 (0.33%)
Gingivitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Ileus ^* 1	5/605 (0.83%)	4/611 (0.65%)
Colitis ^* 1	1/605 (0.17%)	4/611 (0.65%)
Small intestinal obstruction ^* 1	2/605 (0.33%)	5/611 (0.82%)
Anal haemorrhage ^* 1	1/605 (0.17%)	0/611 (0.00%)
Faecal incontinence ^* 1	1/605 (0.17%)	0/611 (0.00%)
Gastrointestinal haemorrhage ^* 1	0/605 (0.00%)	3/611 (0.49%)
Gastrointestinal inflammation ^* 1	0/605 (0.00%)	3/611 (0.49%)
Periodontitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Gastrointestinal obstruction ^* 1	2/605 (0.33%)	1/611 (0.16%)
Haematemesis ^* 1	2/605 (0.33%)	0/611 (0.00%)
Mechanical ileus ^* 1	2/605 (0.33%)	1/611 (0.16%)
Colitis ischaemic ^* 1	0/605 (0.00%)	1/611 (0.16%)
Colonic obstruction ^* 1	0/605 (0.00%)	2/611 (0.33%)
Duodenal ulcer perforation ^* 1	1/605 (0.17%)	1/611 (0.16%)
Peritonitis ^* 1	1/605 (0.17%)	1/611 (0.16%)
Small intestinal perforation ^* 1	1/605 (0.17%)	1/611 (0.16%)
Subileus ^* 1	0/605 (0.00%)	2/611 (0.33%)
Colonic fistula ^* 1	1/605 (0.17%)	0/611 (0.00%)
Duodenal obstruction ^* 1	1/605 (0.17%)	0/611 (0.00%)
Duodenal ulcer haemorrhage ^* 1	0/605 (0.00%)	1/611 (0.16%)
Enterocolitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Enterocutaneous fistula ^* 1	0/605 (0.00%)	1/611 (0.16%)
Gastrointestinal hypomotility ^* 1	1/605 (0.17%)	0/611 (0.00%)
Gastrointestinal perforation ^* 1	1/605 (0.17%)	0/611 (0.00%)
Ileal perforation ^* 1	0/605 (0.00%)	1/611 (0.16%)
Ileitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Large intestinal haemorrhage ^* 1	0/605 (0.00%)	1/611 (0.16%)
Large intestinal obstruction ^* 1	0/605 (0.00%)	1/611 (0.16%)
Lower gastrointestinal haemorrhage ^* 1	0/605 (0.00%)	1/611 (0.16%)
Mallory-weiss syndrome ^* 1	0/605 (0.00%)	1/611 (0.16%)
Mesenteric vein thrombosis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Neutropenic colitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pancreatitis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Rectal obstruction ^* 1	0/605 (0.00%)	1/611 (0.16%)
Rectal stenosis ^* 1	1/605 (0.17%)	0/611 (0.00%)
General disorders
Fatigue ^* 1	3/605 (0.50%)	2/611 (0.33%)
Asthenia ^* 1	4/605 (0.66%)	5/611 (0.82%)
Pyrexia ^* 1	15/605 (2.48%)	10/611 (1.64%)
Oedema peripheral ^* 1	3/605 (0.50%)	0/611 (0.00%)
Disease progression ^* 1	14/605 (2.31%)	16/611 (2.62%)
Pain ^* 1	1/605 (0.17%)	2/611 (0.33%)
Non-cardiac chest pain ^* 1	1/605 (0.17%)	2/611 (0.33%)
Malaise ^* 1	0/605 (0.00%)	1/611 (0.16%)
Thrombosis in device ^* 1	0/605 (0.00%)	2/611 (0.33%)
General physical health deterioration ^* 1	1/605 (0.17%)	1/611 (0.16%)
Medical device complication ^* 1	0/605 (0.00%)	1/611 (0.16%)
Death ^* 1	1/605 (0.17%)	2/611 (0.33%)
Suprapubic pain ^* 1	1/605 (0.17%)	0/611 (0.00%)
Mucosal inflammation ^* 1	0/605 (0.00%)	1/611 (0.16%)
Sudden death ^* 1	1/605 (0.17%)	0/611 (0.00%)
Hepatobiliary disorders
Hyperbilirubinaemia ^* 1	4/605 (0.66%)	2/611 (0.33%)
Cholecystitis ^* 1	1/605 (0.17%)	4/611 (0.65%)
Biliary colic ^* 1	1/605 (0.17%)	0/611 (0.00%)
Cholangitis ^* 1	1/605 (0.17%)	1/611 (0.16%)
Hepatic function abnormal ^* 1	1/605 (0.17%)	0/611 (0.00%)
Jaundice cholestatic ^* 1	1/605 (0.17%)	0/611 (0.00%)
Bile duct obstruction ^* 1	0/605 (0.00%)	1/611 (0.16%)
Hepatic haemorrhage ^* 1	0/605 (0.00%)	1/611 (0.16%)
Hepatitis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Hepatotoxicity ^* 1	1/605 (0.17%)	0/611 (0.00%)
Immune system disorders
Hypersensitivity ^* 1	2/605 (0.33%)	0/611 (0.00%)
Infections and infestations
Urinary tract infection ^* 1	3/605 (0.50%)	8/611 (1.31%)
Upper respiratory tract infection ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pneumonia ^* 1	5/605 (0.83%)	11/611 (1.80%)
Lower respiratory tract infection ^* 1	2/605 (0.33%)	1/611 (0.16%)
Device related infection ^* 1	6/605 (0.99%)	5/611 (0.82%)
Bronchitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Cystitis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Oral candidiasis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Neutropenic infection ^* 1	5/605 (0.83%)	4/611 (0.65%)
Sinusitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Viral infection ^* 1	1/605 (0.17%)	0/611 (0.00%)
Pharyngitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Respiratory tract infection ^* 1	0/605 (0.00%)	1/611 (0.16%)
Sepsis ^* 1	5/605 (0.83%)	8/611 (1.31%)
Gastroenteritis ^* 1	2/605 (0.33%)	1/611 (0.16%)
Catheter site infection ^* 1	0/605 (0.00%)	3/611 (0.49%)
Infection ^* 1	1/605 (0.17%)	1/611 (0.16%)
Lobar pneumonia ^* 1	5/605 (0.83%)	0/611 (0.00%)
Lung infection ^* 1	1/605 (0.17%)	1/611 (0.16%)
Anal abscess ^* 1	1/605 (0.17%)	1/611 (0.16%)
Diverticulitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Neutropenic sepsis ^* 1	0/605 (0.00%)	3/611 (0.49%)
Perirectal abscess ^* 1	0/605 (0.00%)	3/611 (0.49%)
Subcutaneous abscess ^* 1	0/605 (0.00%)	1/611 (0.16%)
Abscess jaw ^* 1	0/605 (0.00%)	1/611 (0.16%)
Clostridial infection ^* 1	0/605 (0.00%)	1/611 (0.16%)
Oesophageal candidiasis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Septic shock ^* 1	0/605 (0.00%)	2/611 (0.33%)
Appendicitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Bacterial sepsis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Beta haemolytic streptococcal infection ^* 1	0/605 (0.00%)	1/611 (0.16%)
Bronchopneumonia ^* 1	1/605 (0.17%)	0/611 (0.00%)
Device related sepsis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Emphysematous cystitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Enterocolitis infectious ^* 1	0/605 (0.00%)	1/611 (0.16%)
Escherichia infection ^* 1	1/605 (0.17%)	0/611 (0.00%)
Pelvic abscess ^* 1	0/605 (0.00%)	1/611 (0.16%)
Perinephric abscess ^* 1	0/605 (0.00%)	1/611 (0.16%)
Peritonitis bacterial ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pneumonia streptococcal ^* 1	0/605 (0.00%)	1/611 (0.16%)
Rectal abscess ^* 1	0/605 (0.00%)	1/611 (0.16%)
Staphylococcal sepsis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Viral diarrhoea ^* 1	1/605 (0.17%)	0/611 (0.00%)
Injury, poisoning and procedural complications
Fall ^* 1	1/605 (0.17%)	0/611 (0.00%)
Post procedural haemorrhage ^* 1	1/605 (0.17%)	2/611 (0.33%)
Skin laceration ^* 1	1/605 (0.17%)	0/611 (0.00%)
Gastrointestinal stoma complication ^* 1	0/605 (0.00%)	3/611 (0.49%)
Head injury ^* 1	1/605 (0.17%)	0/611 (0.00%)
Incisional hernia ^* 1	0/605 (0.00%)	1/611 (0.16%)
Wound dehiscence ^* 1	1/605 (0.17%)	0/611 (0.00%)
Ankle fracture ^* 1	0/605 (0.00%)	1/611 (0.16%)
Femoral neck fracture ^* 1	1/605 (0.17%)	0/611 (0.00%)
Femur fracture ^* 1	1/605 (0.17%)	0/611 (0.00%)
Limb traumatic amputation ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pneumothorax traumatic ^* 1	1/605 (0.17%)	0/611 (0.00%)
Subdural haematoma ^* 1	0/605 (0.00%)	1/611 (0.16%)
Investigations
Neutrophil count decreased ^* 1	0/605 (0.00%)	1/611 (0.16%)
Blood creatinine increased ^* 1	2/605 (0.33%)	2/611 (0.33%)
Blood bilirubin increased ^* 1	1/605 (0.17%)	0/611 (0.00%)
Haemoglobin decreased ^* 1	0/605 (0.00%)	1/611 (0.16%)
International normalised ratio increased ^* 1	0/605 (0.00%)	1/611 (0.16%)
Blood creatine increased ^* 1	0/605 (0.00%)	1/611 (0.16%)
C-reactive protein increased ^* 1	1/605 (0.17%)	0/611 (0.00%)
Hepatic enzyme increased ^* 1	0/605 (0.00%)	1/611 (0.16%)
Metabolism and nutrition disorders
Decreased appetite ^* 1	2/605 (0.33%)	3/611 (0.49%)
Dehydration ^* 1	7/605 (1.16%)	24/611 (3.93%)
Diabetes mellitus ^* 1	0/605 (0.00%)	1/611 (0.16%)
Hypoglycaemia ^* 1	0/605 (0.00%)	2/611 (0.33%)
Hyponatraemia ^* 1	0/605 (0.00%)	2/611 (0.33%)
Failure to thrive ^* 1	1/605 (0.17%)	0/611 (0.00%)
Hypoproteinaemia ^* 1	1/605 (0.17%)	0/611 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	4/605 (0.66%)	3/611 (0.49%)
Bone pain ^* 1	1/605 (0.17%)	1/611 (0.16%)
Musculoskeletal chest pain ^* 1	2/605 (0.33%)	0/611 (0.00%)
Bursitis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Osteonecrosis of jaw ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pathological fracture ^* 1	1/605 (0.17%)	0/611 (0.00%)
Fistula ^* 1	0/605 (0.00%)	1/611 (0.16%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain ^* 1	3/605 (0.50%)	2/611 (0.33%)
Cancer pain ^* 1	1/605 (0.17%)	1/611 (0.16%)
Tumour pain ^* 1	1/605 (0.17%)	1/611 (0.16%)
Metastases to central nervous system ^* 1	1/605 (0.17%)	1/611 (0.16%)
Benign neoplasm of cervix uteri ^* 1	0/605 (0.00%)	1/611 (0.16%)
Bladder cancer ^* 1	0/605 (0.00%)	1/611 (0.16%)
Tumour associated fever ^* 1	0/605 (0.00%)	1/611 (0.16%)
Nervous system disorders
Headache ^* 1	1/605 (0.17%)	3/611 (0.49%)
Peripheral sensory neuropathy ^* 1	0/605 (0.00%)	1/611 (0.16%)
Syncope ^* 1	3/605 (0.50%)	1/611 (0.16%)
Presyncope ^* 1	0/605 (0.00%)	1/611 (0.16%)
Transient ischaemic attack ^* 1	0/605 (0.00%)	2/611 (0.33%)
Migraine ^* 1	0/605 (0.00%)	1/611 (0.16%)
Spinal cord compression ^* 1	1/605 (0.17%)	0/611 (0.00%)
Aphasia ^* 1	1/605 (0.17%)	0/611 (0.00%)
Brachial plexopathy ^* 1	1/605 (0.17%)	0/611 (0.00%)
Cerebrovascular accident ^* 1	0/605 (0.00%)	1/611 (0.16%)
Coma ^* 1	0/605 (0.00%)	1/611 (0.16%)
Convulsion ^* 1	0/605 (0.00%)	1/611 (0.16%)
Disturbance in attention ^* 1	1/605 (0.17%)	0/611 (0.00%)
Haemorrhage intracranial ^* 1	1/605 (0.17%)	0/611 (0.00%)
Metabolic encephalopathy ^* 1	0/605 (0.00%)	1/611 (0.16%)
Psychiatric disorders
Anxiety ^* 1	0/605 (0.00%)	1/611 (0.16%)
Depression ^* 1	0/605 (0.00%)	1/611 (0.16%)
Confusional state ^* 1	2/605 (0.33%)	2/611 (0.33%)
Hallucination ^* 1	0/605 (0.00%)	1/611 (0.16%)
Mental status changes ^* 1	0/605 (0.00%)	1/611 (0.16%)
Renal and urinary disorders
Proteinuria ^* 1	0/605 (0.00%)	1/611 (0.16%)
Haematuria ^* 1	2/605 (0.33%)	1/611 (0.16%)
Urinary retention ^* 1	1/605 (0.17%)	4/611 (0.65%)
Urinary incontinence ^* 1	1/605 (0.17%)	0/611 (0.00%)
Hydronephrosis ^* 1	3/605 (0.50%)	1/611 (0.16%)
Renal failure acute ^* 1	0/605 (0.00%)	2/611 (0.33%)
Renal impairment ^* 1	0/605 (0.00%)	2/611 (0.33%)
Renal vein thrombosis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Bladder neck obstruction ^* 1	0/605 (0.00%)	1/611 (0.16%)
Nephrotic syndrome ^* 1	0/605 (0.00%)	1/611 (0.16%)
Renal failure ^* 1	1/605 (0.17%)	1/611 (0.16%)
Cystitis haemorrhagic ^* 1	0/605 (0.00%)	1/611 (0.16%)
Nephrolithiasis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Obstructive uropathy ^* 1	1/605 (0.17%)	0/611 (0.00%)
Urinary tract obstruction ^* 1	1/605 (0.17%)	0/611 (0.00%)
Reproductive system and breast disorders
Pelvic pain ^* 1	1/605 (0.17%)	0/611 (0.00%)
Balanitis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Respiratory, thoracic and mediastinal disorders
Epistaxis ^* 1	0/605 (0.00%)	2/611 (0.33%)
Cough ^* 1	0/605 (0.00%)	1/611 (0.16%)
Dyspnoea ^* 1	3/605 (0.50%)	3/611 (0.49%)
Oropharyngeal pain ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pulmonary embolism ^* 1	12/605 (1.98%)	19/611 (3.11%)
Pleural effusion ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pleuritic pain ^* 1	0/605 (0.00%)	1/611 (0.16%)
Atelectasis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Interstitial lung disease ^* 1	2/605 (0.33%)	0/611 (0.00%)
Pneumonitis ^* 1	1/605 (0.17%)	1/611 (0.16%)
Pneumothorax ^* 1	0/605 (0.00%)	2/611 (0.33%)
Acute pulmonary oedema ^* 1	0/605 (0.00%)	1/611 (0.16%)
Acute respiratory distress syndrome ^* 1	0/605 (0.00%)	1/611 (0.16%)
Acute respiratory failure ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pneumomediastinum ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pneumonia aspiration ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pulmonary artery thrombosis ^* 1	0/605 (0.00%)	1/611 (0.16%)
Pulmonary hypertension ^* 1	0/605 (0.00%)	1/611 (0.16%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^* 1	0/605 (0.00%)	1/611 (0.16%)
Vascular disorders
Hypertension ^* 1	0/605 (0.00%)	10/611 (1.64%)
Deep vein thrombosis ^* 1	7/605 (1.16%)	7/611 (1.15%)
Hypotension ^* 1	0/605 (0.00%)	1/611 (0.16%)
Jugular vein thrombosis ^* 1	2/605 (0.33%)	0/611 (0.00%)
Vena cava thrombosis ^* 1	2/605 (0.33%)	2/611 (0.33%)
Pelvic venous thrombosis ^* 1	2/605 (0.33%)	0/611 (0.00%)
Orthostatic hypotension ^* 1	0/605 (0.00%)	1/611 (0.16%)
Subclavian vein thrombosis ^* 1	2/605 (0.33%)	1/611 (0.16%)
Circulatory collapse ^* 1	1/605 (0.17%)	1/611 (0.16%)
Thrombophlebitis ^* 1	1/605 (0.17%)	0/611 (0.00%)
Arterial thrombosis limb ^* 1	1/605 (0.17%)	0/611 (0.00%)
Embolism arterial ^* 1	0/605 (0.00%)	1/611 (0.16%)
Hypovolaemic shock ^* 1	0/605 (0.00%)	1/611 (0.16%)
Superior vena caval occlusion ^* 1	0/605 (0.00%)	1/611 (0.16%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 13.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo/FOLFIRI	Aflibercept/FOLFIRI
	Affected / at Risk (%)	Affected / at Risk (%)
Total	575/605 (95.04%)	599/611 (98.04%)
Blood and lymphatic system disorders
Neutropenia ^* 1	202/605 (33.39%)	229/611 (37.48%)
Gastrointestinal disorders
Diarrhoea ^* 1	335/605 (55.37%)	411/611 (67.27%)
Nausea ^* 1	327/605 (54.05%)	322/611 (52.70%)
Stomatitis ^* 1	199/605 (32.89%)	304/611 (49.75%)
Vomiting ^* 1	199/605 (32.89%)	194/611 (31.75%)
Abdominal pain ^* 1	141/605 (23.31%)	158/611 (25.86%)
Constipation ^* 1	146/605 (24.13%)	135/611 (22.09%)
Abdominal pain upper ^* 1	46/605 (7.60%)	63/611 (10.31%)
Dyspepsia ^* 1	56/605 (9.26%)	50/611 (8.18%)
Haemorrhoids ^* 1	13/605 (2.15%)	34/611 (5.56%)
Proctalgia ^* 1	11/605 (1.82%)	32/611 (5.24%)
General disorders
Fatigue ^* 1	234/605 (38.68%)	292/611 (47.79%)
Asthenia ^* 1	77/605 (12.73%)	109/611 (17.84%)
Pyrexia ^* 1	73/605 (12.07%)	77/611 (12.60%)
Oedema peripheral ^* 1	42/605 (6.94%)	52/611 (8.51%)
Infections and infestations
Urinary tract infection ^* 1	35/605 (5.79%)	51/611 (8.35%)
Investigations
Weight decreased ^* 1	87/605 (14.38%)	195/611 (31.91%)
Metabolism and nutrition disorders
Decreased appetite ^* 1	143/605 (23.64%)	195/611 (31.91%)
Dehydration ^* 1	12/605 (1.98%)	33/611 (5.40%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	69/605 (11.40%)	72/611 (11.78%)
Arthralgia ^* 1	40/605 (6.61%)	31/611 (5.07%)
Pain in extremity ^* 1	33/605 (5.45%)	34/611 (5.56%)
Nervous system disorders
Headache ^* 1	53/605 (8.76%)	136/611 (22.26%)
Dizziness ^* 1	53/605 (8.76%)	36/611 (5.89%)
Dysgeusia ^* 1	32/605 (5.29%)	42/611 (6.87%)
Neuropathy peripheral ^* 1	30/605 (4.96%)	34/611 (5.56%)
Lethargy ^* 1	28/605 (4.63%)	33/611 (5.40%)
Psychiatric disorders
Insomnia ^* 1	45/605 (7.44%)	47/611 (7.69%)
Renal and urinary disorders
Proteinuria ^* 1	9/605 (1.49%)	63/611 (10.31%)
Respiratory, thoracic and mediastinal disorders
Epistaxis ^* 1	45/605 (7.44%)	168/611 (27.50%)
Dysphonia ^* 1	20/605 (3.31%)	155/611 (25.37%)
Cough ^* 1	58/605 (9.59%)	67/611 (10.97%)
Dyspnoea ^* 1	51/605 (8.43%)	69/611 (11.29%)
Oropharyngeal pain ^* 1	19/605 (3.14%)	45/611 (7.36%)
Rhinorrhoea ^* 1	11/605 (1.82%)	38/611 (6.22%)
Skin and subcutaneous tissue disorders
Alopecia ^* 1	182/605 (30.08%)	164/611 (26.84%)
Palmar-plantar erythrodysaesthesia syndrome ^* 1	26/605 (4.30%)	67/611 (10.97%)
Rash ^* 1	35/605 (5.79%)	41/611 (6.71%)
Skin hyperpigmentation ^* 1	17/605 (2.81%)	50/611 (8.18%)
Hyperhidrosis ^* 1	33/605 (5.45%)	17/611 (2.78%)
Vascular disorders
Hypertension ^* 1	65/605 (10.74%)	250/611 (40.92%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 13.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study for review and comment at least 45 days (20 days for abstracts) in advance of any submission, and delay publication till the approval of the publication is given in writing by the Sponsor (not to exceed ninety days).

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	International Clinical Development Study Director
Organization:	sanofi-aventis
EMail:	contact-us@sanofi.com

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

Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6.

Chau I, Fakih M, Garcia-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3):657. doi: 10.3390/cancers12030657.

Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12.

Stanel SC, Sjoberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017.

Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomy R, Prausova J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kroning H, Humblet Y, Gravalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9.

Tabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16.

Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. doi: 10.1200/JCO.2012.42.8201. Epub 2012 Sep 4.

Layout table for additonal information

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00561470
Other Study ID Numbers:	EFC10262 EudraCT 2007-000820-42
First Submitted:	November 20, 2007
First Posted:	November 21, 2007
Results First Submitted:	August 17, 2012
Results First Posted:	September 28, 2012
Last Update Posted:	September 28, 2012

To Top