Clinical trial to determine whether Crestor can prevent new colon tumors after surgery

Mar 25 2011

Christiana Care Health System's Helen F. Graham Cancer Center is leading a national clinical trial to determine if Crestor® (Rosuvastatin), a cholesterol-lowering drug, can prevent new colon tumors from forming after colon cancer surgery.

The study seeks to determine if Crestor can stop the growth of tumor cells by blocking some of the enzymes that affect cell growth. The trial will also determine if Crestor can keep new colon tumors from forming after surgery to remove a patient's initial colon cancer.

The study, entitled, "P-5: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer," is conducted under the auspices of the National Cancer Institute by a network of cancer research professionals, the National Surgical Adjuvant Breast and Bowel Project (NSABP). It takes place at more than 200 medical centers throughout North America.

"Previous epidemiological studies looking back at patient data associated with statin use indicate these drugs lower the risk of colorectal cancer, but the evidence remains controversial," says Bruce Boman, M.D., Ph.D., study protocol chair. "Earlier studies were designed to investigate lipid-lowering or cardiovascular endpoints over the short-term rather than tumor development in the long run."

Dr. Boman is director of Cancer Genetics at the Helen F. Graham Cancer Center's Hereditary Cancer Risk Assessment Program. He is also a scientist at the Center for Translational Cancer Research who investigates how cancer stem cells drive tumor growth.

The study aims to recruit 1,740 patients who have recently been diagnosed with early stage colon cancer and who were not already taking statins for high cholesterol. Patients will be randomly assigned to one of two groups. Each group will take one pill a day for five years. One group will receive Rosuvastatin, the other a placebo.

Investigators also will look at participants with a family history of colorectal cancer and those who take a daily low or high dose of aspirin. Previous studies indicate non-steroidal anti-inflammatory drugs, including aspirin, and statin drugs, like Crestor, work together. Further evidence of this relationship could support reducing doses to improve the risk and benefits of these two types of drugs.

SOURCE Christiana Care Health System