Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors
Status:
Recruiting
Trial end date:
2024-02-14
Target enrollment:
Participant gender:
Summary
This open-label, non-randomized study aims to determine the anti-inflammatory effect of
colchicine on the reduction of peripheral blood CRP in patients with solid tumors or
localized urothelial cancer. There are two cohorts, which will enroll separately and
parallelly. Cohort 1 will include two successive groups with metastatic solid tumors (15
patients will receive low-dose colchicine and 15 for high-dose colchicine). In Cohort 2, 15
patients with post-radical surgery for high-risk clinically localized urothelial cancer will
be enrolled. The primary outcome, post-treatment decline in CRP level, a continuous measure,
will be defined as the maximum percentage decline from baseline in post-treatment CRP value
within three cycles of colchicine, where the baseline value is measured before any treatment
is initiated.