ecrin-mdr-crcClinical2005Cancer-Bowel-Back passage (rectum) or large bowel (colon)Metastatic colorectal cancerMetastatic Colorectal CancerCancer-bowel-back Passage (rectum) Or Large Bowel (colon)Interventionalhttps://newmdr.ecrin.org/Study/2451960Australia11ECRIN MDRRecruitingfalseRandomised Phase II trial of irinotecan with hyaluronic acid (HyCAMP) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapyInterventions: This is an open-label, randomized Phase II study of HyCAMP versus irinotecan as second-line or subsequent-line treatment for metastatic colorectal cancer, for patients who have previously received 5-FU based chemotherapy. The mixture of HA and irinotecan will be given by intravenous infusion on day 1 of a 3-week cycle, up to a maximum of 8 cycles, with the control arm receiving irinotecan alone in the same treatment schedule. The treatment dose of HyCAMP has been shown to be safe in a recently completed Phase I study combining irinotecan with HA. Patients will be randomized in a 1:1 fashion to either 1) HyCAMP (irinotecan and HA) or 2) Control arm (irinotecan) Primary outcome(s): Incidence of Grade 3 and 4 diarrhoea[] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy2005-11-152451960ACTRN12605000119695