At a glance
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A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
In Brief
A Phase 3 clinical trial evaluating 5 fluorouracil, irinotecan, and 3 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 768 participants across 132 sites in 34 countries.
Detailed Summary
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
Study Details
Timeline
Interventions
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
180mg/m2 iv day 1 every 14 days
200mg/m2 iv; day 1 every 14 days
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
180mg/m2 iv day 1 every 14 days
200mg/m2 iv; day 1 every 14 days
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period