Colorectal Cancer Metastatic

Sponsor
Sanofi
Study ID
NCT01670721
Phase
PHASE3
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • AFLIBERCEPT — DRUG
    Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
  • Irinotecan — DRUG
    Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
  • Fluorouracil — DRUG
    Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
  • Leucovorin — DRUG
    Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Oct 2016
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)
    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.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days) ]

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