Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: A randomized phase II trial

Abstract

Purpose: The objective of this study was to conduct a randomised phase II study in second-line metastatic colorectal cancer with the purpose of confirming preliminary clinical data indicating that the formulation of irinotecan with the drug carrier, hyaluronan (HA) reduced toxicity of the drug. Methods: Irinotecan-naïve patients were randomized to receive either irinotecan (350 mg/m2) or HA-Irinotecan (HA 1,000 mg/m2 and irinotecan at 350 mg/m2) every 3 weeks for a maximum of eight cycles. Results: Seventy-six patients (41 HA-Irinotecan and 35 irinotecan-alone) were enrolled. There was no significant difference in any individual, or overall, grade 3 or 4 toxicity. There was a trend for incre..