Pre-operative Decitabine in Colon Cancer: a Proof of Principle Study
Status:
Terminated
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
Background of the study: Colon cancer is the second leading cause of cancer-related death
world wide.
Although patients presenting with early disease (stage I-III) can be cured, prognosis varies
from 90% in stage I to 50-80% in stage II and III. Therefore, prevention of metastases after
early disease is of utmost importance. Derepression of Wnt targets may provide a novel target
for therapy.
Objectives: The primary objective of the study is to assess in patients with primary colon
cancer whether short-course pre-operative treatment with decitabine can increase Wnt target
gene expression as measured in resected tumors compared to pretreatment biopsies. The
secondary objective of the study is to assess in patients with primary colon cancer whether
short-course pre-operative treatment with decitabine can revert CpG methylation and induce
more favorable tumor characteristics as measured in resected tumors compared to pretreatment
biopsies. The tertiary objective is to compare changes in Wnt target gene expression, CpG
methylation and tumor characteristics for Wnt methylated and nonmethylated tumors as measured
in resected tumors compared to pretreatment biopsies and identify new stratification markers.
Phase:
N/A
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)