Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer

Completed · Phase 2

Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01105377

Run by

National Cancer Institute (NCI)

People needed

47

Starts

2010-04-01

Expected to finish

2014-05-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic colorectal cancer
• Measurable disease
• Patient has failed ≥ 2 prior chemotherapy regimens
• Not a candidate for curative resection
• No CNS metastases within ≤ 2 years
• Treatment for brain metastasis and whole brain disease that has remained stable for > 3 months allowed
• Patients who have not been treated with steroid therapy may be allowed
• ECOG performance status 0-1
• Life expectancy ≥ 12 weeks
• Leukocytes ≥ 3,000/mm\^3
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Negative pregnancy test
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Sensory neuropathy ≤ grade 2 allowed
• Willing to provide tissue and blood samples
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat, azacitidine, mannitol, or other agents used in the study
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• NYHA class II-IV symptomatic congestive heart failure
• Unstable angina pectoris

Where it is running

• 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 — St 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

Full record on ClinicalTrials.gov

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