Pilot study of SIR-Spheres plus systemic chemotherapy with irinotecan alone in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel

Interventions: This dose escalation study is designed to assess the safety and efficacy of a single dose of SIR-Spheres when used in combination with irinotecan over a 9 treatment cycle duration. Each 3 week cycle of treatment with irinotecan on days 1 and 8 followed by a rest week on day 15.
Primary outcome(s): Toxicity[Assessed over the duration of treatment and up to 1 month after the conclusion of protocol chemotherapy using UICC criteria];Response Rate[Assessed up until the scan following the completion of protocol chemotherapy]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy