HAIP-6192

Official Title

A PHASE II STUDY OF THE RATE OF CONVERSION TO COMPLETE RESECTION IN PATIENTS WITH INITIALLY INOPERABLE HEPATIC-ONLY METASTASES FROM COLORECTAL CANCER AFTER TREATMENT WITH HEPATIC ARTERIAL INFUSION WITH FLOXURIDINE AND DEXAMETHASONE IN COMBINATION WITH BEST SYSTEMIC CHEMOTHERAPY

Summary:

The liver pump has been approved in Canada for treatment of colorectal liver metastasis with FUDR (Floxuridine, the study drug). However in Canada, FUDR is not a commercially approved drug although for this study, Health Canada has allowed the use of FUDR. The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on you and your tumour. Liver pump treatment uses a metal pump that is surgically placed in your abdomen and gives chemotherapy directly to your liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously (IV)] and treats the whole body. This type of treatment has been done before and had shown that patients with both pump and systemic chemotherapy had improved results to those who received only systemic chemotherapy.

Trial Description

Primary Outcome:

• To assess the rate of conversion to complete resection in patients with initially inoperable hepatic-only metastases due to colorectal cancer after treatment with HAI of FUDR and Dex with best systemic treatment.

Secondary Outcome:

• To evaluate time to progression (TTP), disease-free survival (DFS) and overall survival.
• To determine overall response rate.
• To evaluate the safety and tolerability of HAI FUDR + best systemic chemotherapy.

Trial description: This is a single arm, open-label, single-institution trial. Therapy will be given over a 4-week cycle. HAI Pump therapy with FUDR will be administered on Day 1 of each cycle. The pump will be emptied and filled with heparin and normal saline on Day 15. Best systemic chemotherapy will be administered on Day 1 and Day 15 of each cycle. Treatment recycles on day 29. Patients will be registered to one of two best systemic treatment regimens depending on their prior chemotherapy history. Tumor response will be monitored by CT scan every 2 to 3 cycles. Resectability assessment based on CT scan results will be performed every 2 to 3 cycles beginning on cycle 4 and patients will undergo surgery for potential resection when deemed potentially resectable at a multidisciplinary tumour board.