Metastatic Pancreatic Adenocarcinoma Clinical Trial
Official title:
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Advanced Pancreatic Cancer That Has Progressed Through One or More Lines of Therapy
Patients with pancreatic cancer which has stopped responding to one or more chemotherapy
drugs are asked to take part in this study. The study hopes to find out whether decitabine,
the drug being studied, will have an effect on pancreatic cancer. The decitabine is being
given at a lower dose than its approved use. It is also being given with another drug,
tetrahydrouridine (THU), to improve the exposure of your pancreatic cancer cells to
decitabine.
The purpose of this study is to determine if the drug combination of decitabine and
tetrahydrouridine can recognize a certain DNA target in your cancer. All cells have DNA
within them, and tumor cells have abnormal DNA.
Primary Objective The primary goal of this pilot study is to detect decitabine therapy
induced DNMT1 protein level decreases with an effect size of 1 using a paired t-test and
alpha=0.05. The effect size is defined as the difference in mean DNMT1-protein levels between
post-treatment and pre-treatment divided by the standard deviation and is thus a metric of
change in the natural units of the distribution, its standard deviation. Our goal is thus to
detect drops in DNMT1 of at least one standard deviation.
Secondary Objectives Secondary goals include correlating DNMT1 decreases with clinical
response (measured by Response Evaluation Criteria in Solid Tumors [RECIST1.1]), using
logistic regression; time to relapse, using a Cox model; tolerability and safety assessment
by toxicity characterization using CTCAEv4.
Study Design Single-arm, open-label, proof-of-concept clinical trial in patients with
metastatic pancreatic cancer that has progressed on one or more lines of systemic therapy.
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