Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Sanofi
Study ID
NCT01571284
Phase
PHASE3
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AFLIBERCEPT AVE0005 — DRUG
    Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
  • FOLFIRI — DRUG
    irinotecan, 5-FU and leucovorin

Study Details

Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population

Key Dates

Start date
May 30, 2012
Status verified
Mar 2018
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

Enrollment
781 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
    Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m\^2 IV infusion over 90 minutes and Leucovorin 400 mg/m\^2 IV infusion over 120 minutes at the same time followed by 5-Fluorouracil (5-FU) 400 mg/m\^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m\^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) ]

Locations (12)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840-002Muscle ShoalsAlabama35661-
Investigational Site Number 840-008CoronaCalifornia92879-
Investigational Site Number 840-007Fountain ValleyCalifornia92708-
Investigational Site Number 840-004RiversideCalifornia92501-
Investigational Site Number 840-006IndianapolisIndiana46254-
Investigational Site Number 840-011MetairieLouisiana70006-
Investigational Site Number 840-001RockvilleMaryland20850-
Investigational Site Number 840-010Howell TownshipNew Jersey07731-
Investigational Site Number 840-012AlbuquerqueNew Mexico87106-
Investigational Site Number 840-009FarmingtonNew Mexico87401-
Investigational Site Number 840-003Lake SuccessNew York11042-
Investigational Site Number 840-005MiddletownOhio45042-

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