A Study of Aflibercept Versus Placebo With FOLFIRI in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin Chemotherapy
- Registration Number
- NCT01661270
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease.
Secondary Objectives:
To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers.
- Detailed Description
Screening occurred from signed informed consent to randomization (up to 21 days). A treatment cycle was defined as a 2 week-period. All participants were followed during the study treatment and follow-up period until death or study cut off date, which ever comes first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m\^2 IV infusion and leucovorin 400 mg/m\^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m\^2 followed by continuous IV infusion 2400 mg/m\^2. Aflibercept Aflibercept Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m\^2 IV infusion and leucovorin 400 mg/m\^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m\^2 followed by continuous IV infusion 2400 mg/m\^2.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 26.7 months PFS was defined as the time interval from the date of randomization to the date of first observation of either tumor progression or death due to any cause. Tumor assessment was performed by Independent Review Committee (IRC) as per response evaluation criteria in solid tumors (RECIST) version 1.0. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 31.6 months OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the earliest between the last date of the participants was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.
Percentage of Participants With Objective Response 26.6 months Objective response rate was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by Investigators and the IRC according to RECIST 1.0 criteria, relative to the total number of participants in the relevant analysis population. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Trial Locations
- Locations (37)
Investigational Site Number 156001
🇨🇳Beijing, China
Investigational Site Number 156003
🇨🇳Beijing, China
Investigational Site Number 156016
🇨🇳Chengdu, China
Investigational Site Number 156002
🇨🇳Beijing, China
Investigational Site Number 156004
🇨🇳Beijing, China
Investigational Site Number 156020
🇨🇳Chongqing, China
Investigational Site Number 156021
🇨🇳Fuzhou, China
Investigational Site Number 156010
🇨🇳Hangzhou, China
Investigational Site Number 156011
🇨🇳Hangzhou, China
Investigational Site Number 156009
🇨🇳Hangzhou, China
Investigational Site Number 156015
🇨🇳Harbin, China
Investigational Site Number 156006
🇨🇳Shanghai, China
Investigational Site Number 156014
🇨🇳Shenyang, China
Investigational Site Number 156007
🇨🇳Shanghai, China
Investigational Site Number 156019
🇨🇳Wuhan, China
Investigational Site Number 156018
🇨🇳Wuhan, China
Investigational Site Number 156005
🇨🇳Tianjin, China
Investigational Site Number 156017
🇨🇳Xi'An, China
Investigational Site Number 392004
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392009
🇯🇵Gifu-Shi, Japan
Investigational Site Number 392005
🇯🇵Kochi-Shi, Japan
Investigational Site Number 392007
🇯🇵Kumamoto-Shi, Japan
Investigational Site Number 392008
🇯🇵Nagakute-Shi, Japan
Investigational Site Number 158003
🇨🇳Taipai, Taiwan
Investigational Site Number 344002
🇭🇰Hong Kong, Hong Kong
Investigational Site Number 392006
🇯🇵Amagasaki-Shi, Japan
Investigational Site Number 392003
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392002
🇯🇵Kitaadachi-Gun, Japan
Investigational Site Number 392001
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392010
🇯🇵Takatsuki-Shi, Japan
Investigational Site Number 702002
🇸🇬Singapore, Singapore
Investigational Site Number 702001
🇸🇬Singapore, Singapore
Investigational Site Number 158002
🇨🇳Taipei, Taiwan
Investigational Site Number 156008
🇨🇳Guangzhou, China
Investigational Site Number 156012
🇨🇳Nanjing, China
Investigational Site Number 156013
🇨🇳Nanjing, China
Investigational Site Number 344001
🇭🇰Shatin, Nt, Hong Kong