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ProtocolTitle
P-5Statin Polyp Prevention Trial in Patients with Resected Colon Cancer (1798)
  • Eligibility: click to view information

    DISEASE CHARACTERISTICS:

    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
    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)
    PATIENT CHARACTERISTICS:

    ECOG performance status 0-1
    Serum creatinine = 1.5 times upper limit of normal (ULN)
    AST or ALT = 3.0 times ULN (if both AST and ALT were performed, the higher value must be used to determine eligibility)
    Total bilirubin = 1.5 times 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
    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 (determination of acceptable fasting lipid values should be in accordance with current dyslipidemia management guidelines)
    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
    PRIOR CONCURRENT THERAPY:

    See Disease Characteristics
    More than 30 days since prior statins
    More than 30 days since prior investigational agents
    No concurrent chronic use of NSAIDs

    Concurrent cardioprotective low-dose aspirin allowed provided there is no clinically significant toxicity, as determined by the investigator, that would preclude continuation of aspirin AND patient is willing to continue the same dose (81 mg or 325 mg) throughout study therapy
    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


  • Consent Forms: P-5 Consent
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