The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
Participants were * randomized at baseline (treatment was initiated with 3 days of randomization) * administered treatment in cycles of 14-days till a study withdrawal criterion was met * followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study. The criteria for discontinuation of study treatment for a participant are: * participant (or legal representative) chose to withdraw from treatment * the investigator thought that continuation of the study would be detrimental to the participants well-being due to * disease progression * unacceptable AEs * intercurrent illnesses * non-compliance to the study protocol * participant was lost to follow-up * participant was unblinded for the investigational treatment
4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1 The FOLFIRI regimen included: * 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: * 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: * 5-FU 2400 mg/m² continuous IV infusion over 46-hours
The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1 The FOLFIRI regimen included: * 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: * 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: * 5-FU 2400 mg/m² continuous IV infusion over 46-hours
Bahía Blanca, Argentina
Buenos Aires, Argentina
Ciudad de Buenos Aires, Argentina
Salta, Argentina