Recurrent Rectal Cancer Clinical Trial
Official title:
Phase II Study of Azacitadine and Entinostat in Patients With Metastatic Colorectal Cancer
This phase II trial is studying how well giving azacitidine together with entinostat works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the preliminary efficacy via Response Evaluation Criteria In Solid Tumors
(RECIST) response rate of the combination of azacitidine and entinostat in patients with
metastatic colorectal cancer.
SECONDARY OBJECTIVES:
I. Explore the effects of azacitidine and entinostat on time to progression in patients with
metastatic colorectal cancer.
II. To assess the toxicity for combination azacitidine and entinostat therapy.
TERTIARY OBJECTIVES:
I. Evaluate changes in promoter methylation of selected genes from DNA in circulating serum
samples.
II. To determine changes in histone deacetylase activity and acetylation of H3 and H4
histones in pre- and post-treatment tumor biopsies.
III. To evaluate correlations between these molecular effects and clinical outcomes
(response, time to progression).
IV. To correlate response rates by RECIST criteria versus response rates determined be EASL
(change in tumor enhancement).
OUTLINE: This is a multicenter study.
Patients receive azacitidine subcutaneously on days 1-5 and 8-10 and oral entinostat on days
3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
Blood and tumor tissue samples are collected at baseline and periodically during courses 1-3
for DNA methylation, histone deacetylation activity, and acetylation of H3 and H4 histones
analysis by PCR, western blot, and RT-PCR assays. Pharmacogenomic studies may also be
conducted.
After completion of study therapy, patients are followed up every 3-6 months for up to 3
years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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