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NSABP P-5

Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

PURPOSE: This randomized phase III trial is studying rosuvastatin (Crestor) to see how well it works compared with placebo in treating patients with stage I, II or III colon cancer that was removed by surgery.

RATIONALE: Rosuvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving rosuvastatin after surgery may kill any tumor cells that remain after surgery. It may also keep polyps from forming or colon cancer from coming back. It is not yet known whether rosuvastatin is more effective than a placebo in treating colon cancer that was removed by surgery.

OUTLINE: This is a multicenter study sponsored by the National Cancer Institute. Patients are divided according to family history of a first-degree relative with colorectal cancer (yes vs no), intended aspirin dose (none vs 81 mg vs 325 mg), and adjuvant therapy for colon cancer (yes vs no). Patients are randomized (given an equal chance to receive) 1 of 2 treatment arms.

  • Arm I: Patients receive oral rosuvastatin once daily for 5 years.
  • Arm II: Patients receive oral placebo once daily for 5 years.

Tumor tissue, serum, and blood samples may be collected periodically for biomarker and other analyses.

After completion of study treatment, patients are followed up periodically for up to 2 years.

PATIENT CHARACTERISTICS:

  • Has undergone complete resection of stage I, II or III adenocarcinoma of the colon with curative intent within the past year
  • Has completed adjuvant chemotherapy (if indicated) prior to study admission
  • Has good health, and life expectancy of at least 10 years
  • Does not have classic familial adenomatous polyposis, attenuated familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer (Lynch syndrome)
  • Does not have disease significantly affecting gastrointestinal (GI) function, such as malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel
  • Does not have a history of upper GI bleeding or upper GI ulcerative disease
  • Does not have elevated blood lipid levels with clinical indication for statin therapy or other prescribed medication
  • Has not had any other cancer within the past 5 years except for in situ cancers or basal cell or squamous cell carcinoma of the skin
  • Does not routinely use Non Steroidal Anti-inflammatory Drugs (NSAIDs)
  • Does not take routine drug therapy of cyclosporine, coumarin anticoagulants, gemfibrozil, other lipid-lowering therapies (e.g., fibrates or niacin)
  • MAY use cardio-protective low-dose aspirin, provided there is no clinically significant toxicity, that would preclude continuation of aspirin AND patient is willing to continue the same dose (81 mg or 325 mg) throughout study therapy

FOR FURTHER INFORMATION CONTACT STUDY NURSES

Nona Blauvelt MSN, AOCN 610-738-2522

Blanche Reiner RN, OCN 610-738-2515

Last Updated: 3/19/2014