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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Cancer Treatment
Location: United States, IL

Clinical Trial Details


Research Study Summary

NSABP P-5 Phase III Randomized Study of Adjuvant Rosuvastatin in Patients With Resected Stage I or II Colon Cancer


To compare the effect of rosuvastatin vs placebo on the 5-year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) in patients with resected stage I or II colon cancer.

Patient Inclusion Criteria:

  • Has undergone complete resection of stage I or II adenocarcinoma of the colon with curative intent within the past year
  • Laparoscopically-assisted colectomy is allowed
  • Completed adjuvant therapy (if indicated)
  • Has undergone either a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel preparation within the past 180 days
  • All observed polyps must have been removed
  • Polyps can be removed during colonoscopy or surgery performed prior to randomization
  • Distal border of the tumor located ≥ 12 cm from the anal verge
  • No classic familial adenomatous polyposis, attenuated familial adenomatous polyposis (i.e., = 20 adenomas, either synchronous or metachronous), or hereditary nonpolyposis colorectal cancer (Lynch syndrome)
  • More than 30 days since prior statins
  • More than 30 days since prior investigational agents
  • ECOG performance status 0-1
  • Postoperative serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • Able to swallow oral medication

Patient Exclusion Criteria:

  • No prior total colectomy or total proctocolectomy
  • No concurrent chronic use of NSAIDs
  • No concurrent chronic drug therapy with cyclosporine, coumarin anticoagulants, gemfibrozil, other lipid-lowering therapies (e.g., fibrates or niacin), lopinavir/ritonavir, or drugs (e.g., ketoconazole, spironolactone, or cimetidine) that lower levels or activity of steroid hormones
  • Not pregnant or nursing
  • No malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal (GI) function
  • No history of documented upper GI bleeding or upper GI ulcerative disease
  • No hyperlipidemia with clinical indication for statin therapy or other prescribed medication
  • No inadequately treated hypothyroidism, as determined by the investigator
  • No history of myopathy or rhabdomyolysis
  • No other malignancy within the past 5 years except for in situ cancers or basal cell or squamous cell carcinoma of the skin
  • Deemed by the physician to be at low risk for recurrence
  • No hypersensitivity or intolerance to statins
  • No other non-malignant systemic disease that would preclude rosuvastatin administration or prolonged follow-up

To Learn more



Both Male and Female



Overall Status


Facility Type



Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183165

Date Last Changed: July 17, 2013

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