Conditions: Colorectal Cancer Metastatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 175
Healthy volunteers: no

Brief summary:
Primary Objective:

To evaluate the safety of aflibercept in participants with mCRC treated with irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based regimen (participants similar to those evaluated in the VELOUR trial \[EFC10262, NCT00561470\]) according to side effects prevention and management guidelines.

Secondary Objective:

To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant population.

Detailed description:
Each participant was treated until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal for further treatment (whichever come first). Participants were followed-up during treatment and for at least 30 days after its last study treatment (either Aflibercept or FOLFIRI) administration, up to a maximum of 6 months.

Arms:
arm 1: Aflibercept 4 mg/kg intravenous (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-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 DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.

Interventions: intervention 1: AFLIBERCEPT intervention 2: Irinotecan intervention 3: Fluorouracil intervention 4: Leucovorin
Intervention descriptions: intervention 1: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 2: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 3: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous intervention 4: Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous

Protocol document: