At a glance
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A Phase II Double Blind, Randomised Controlled Trial of VEGF Inhibitor Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Axitinib and Placebo for Colorectal Cancer. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This is a study of Axitinib versus placebo as monotherapy for people with colorectal cancer who have liver metastases and who have relapsed within 6 months of their last chemotherapy regime. The research will also look at the potential of CEHPI (Contrast Enhanced Hepatic Perfusion Index) reduction, a technique developed for this research to measure the changes in how the blood vessels pump blood into the different liver metastases (tumours) and therefore to assess and predict response to treatment.
Study Details
Timeline
Interventions
* All patients randomised to this arm will receive 3mg BD, and increased at 2 weeks to 5mg BD * Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI) * At 8 weeks, after tumour CT RECIST assessments, responders will continue monotherapy. In non-responders, those with disease progression, monotherapy can be continued if patient chooses to continue and if tolerated
* All patients receiving placebo will receive tablets to take BD * Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI)