Statin Polyp Prevention Trial in Patients With Resected Colon Cancer

Inclusion 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

- 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)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Postoperative 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 or other prescribed
medication (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