Randomised 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 chemotherapy

Interventions: 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/efficacy