NCT01670721

Colorectal Cancer Metastatic

A Multicenter, Single Arm, Open Label Clinical Trial Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5-FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	AFLIBERCEPT	Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
DRUG	Irinotecan	Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
DRUG	Fluorouracil	Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
DRUG	Leucovorin	Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-08-22
• Last updated: 2016-11-28
• Results posted: 2016-11-28

Locations

1 site across 1 country: France