Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery
Condition: Colorectal Cancer; Precancerous Condition
MeSH terms: Colonic Neoplasms; Precancerous Conditions
Intervention: rosuvastatin; placebo
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenomatous polyp; stage I colon cancer; stage II colon cancer; adenocarcinoma of the colon

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.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1.

          -  Patients must have the ability to swallow oral medication.

          -  Patients must have resected adenocarcinoma of the colon staged as American Joint
             Committee on Cancer (AJCC) Stage 0, I, II, or III.

          -  Patients must have had surgical resection of the colon adenocarcinoma with curative
             intent within 1 year prior to randomization. (Laparoscopically-assisted colectomy is
             permitted.)

          -  Patients must have completed any adjuvant therapy prior to randomization.

          -  Patients who are taking cardioprotective low-dose aspirin at study entry must not have
             clinically significant toxicity, as determined by the investigator, that precludes
             continuation of aspirin, and the patient must be willing to continue aspirin therapy
             (81 mg or 325 mg) throughout study therapy.

          -  Colonoscopy requirements within 180 days prior to randomization:

          -  The patient must have either undergone a preoperative or postoperative documented
             colonoscopy to the cecum (or small bowel anastomosis) with adequate bowel preparation.

          -  All observed polyps must have been removed. (Polyps can be removed during colonoscopy
             or surgery performed prior to randomization.)

          -  Postoperative serum creatinine performed within 90 days prior to randomization must be
             less than or equal to 1.5 x upper limit of normal (ULN) for the lab.

          -  The following criteria for evidence of adequate hepatic function based on
             postoperative testing performed within 90 days prior to randomization must be met:
             aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than or equal
             to 3.0 x ULN for the lab, and Total bilirubin less than or equal to 1.5 x ULN for the
             lab

        Exclusion Criteria

          -  Tumor with the distal border located less than 12 cm from the anal verge.

          -  Total colectomy or total proctocolectomy.

          -  Classic Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis
             (i.e., 20 or more adenomas, either synchronous or metachronous), or Hereditary
             Nonpolyposis Colorectal Cancer (Lynch Syndrome).

          -  Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of
             the stomach or small bowel, or other disease significantly affecting gastrointestinal
             function.

          -  History of documented upper GI bleeding or upper GI ulcerative disease.

          -  Statin use within 30 days prior to randomization.

          -  Hyperlipidemia with clinical indication for statin therapy or other prescribed
             medication. Determination of acceptable fasting lipid values, within 90 days prior to
             randomization, should be in accordance with current dyslipidemia management
             guidelines.

          -  Unwillingness to discontinue chronic use of nonsteroidal antiinflammatory drugs
             (NSAIDs) (other than cardioprotective low-dose aspirin 81 mg or 325 mg) prior to
             randomization.

          -  Anticipated need for chronic use of NSAIDs (other than cardioprotective low-dose
             aspirin 81 mg or 325 mg).

          -  Inadequately treated hypothyroidism, as determined by the investigator.

          -  History of myopathy or rhabdomyolysis.

          -  Hypersensitivity or intolerance to statins.

          -  Chronic drug therapy with cyclosporine, coumarin anticoagulants, gemfibrozil, some
             other lipid-lowering therapies (fibrates or niacin), lopinavir/ritonavir, or drugs
             (such as ketoconazole, spironolactone, or cimetidine) that lower levels or activity of
             steroid hormones.

          -  Pregnancy or lactation at the time of study entry. (Pregnancy testing must be
             performed within 14 days prior to randomization according to institutional standards
             for women of childbearing potential.)

          -  Previous malignancies unless the patient has been disease-free for 5 or more years
             prior to randomization and is deemed by the physician to be at low risk for
             recurrence. Patients with the following cancers are eligible if diagnosed and treated
             within the past 5 years: all in situ cancers and basal cell and squamous cell
             carcinoma of the skin.

          -  Other non-malignant systemic disease that would preclude a patient from receiving
             rosuvastatin or would prevent prolonged follow-up.

          -  Administration of any investigational agent within 30 days before randomization.