Spots Global Cancer Trial Database for Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer
Official Title: Phase II Study of Azacitadine and Entinostat in Patients With Metastatic Colorectal Cancer
Study ID: NCT01105377
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
University of Southern California/Norris Cancer Center, Los Angeles, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro-Minnesota CCOP, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: Nilofer Azad
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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