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Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery (NSABP P-5)
Statin Polyp Prevention Trial in Patients with Resected Colon Cancer
Status Conditions Phase Study ID
Closed Colon Cancer Phase III NSABP P-5
NCT01011478
Summary

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.

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


Investigator
Tanya Wahl, MD
Location    
Hutchinson Center 206-667-6544  
Olympic Medical Center, Sequim WA 360-683-9895  
Overlake Hospital Medical Center, Bellevue WA 425-688-5407  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 and/or ALT ≤ 3.0 times ULN
  • 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 prior total colectomy or total proctocolectomy
  • 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
Last Updated
February 14, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.