Aspirus Wausau Hospital

Trial Name: Name of Trial: Statin Polyp Prevention Trial in Patients with Resected Colon Cancer Protocol ID Number: NSABP P-5

Protocol ID: NSABP P-5

Eligibility:

Eligibility:

• Patients must be > 18 years of age.
• Patients must have the ability to swallow oral medication.
• Patients must have had surgical resection of the colon adenocarcinoma with curative intent within 1 year prior to enrolling in the study.
• Patients must have completed any adjuvant therapy prior to enrolling in the study.
• Patients who are taking cardioprotective low-dose aspirin at study entry must not have clinically significant toxicity, as determined by the study investigator, that precludes continuation of aspirin, and the patient must be willing to continue aspirin therapy (81 mg or 325 mg) throughout study therapy.
• Patients must be willing to have follow-up colonoscopies at approximately 12, 36, and 60 months following study entry.
• Female patients and male patients with female partners of reproductive potential must agree to use an effective method of contraception during therapy and for at least 6 months after the last dose of study drug.
• Must meet required laboratory values.

Ineligibility:

• Total colectomy or total proctocolectomy
• Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function.
• Unwillingness to discontinue chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81 mg or 325 mg) prior to study entry.
• Anticipated need for chronic use of NSAIDs (other than cardioprotective low-dose aspirin 81 mg or 325 mg).
• History of myopathy or rhabdomyolysis.
• Hypersensitivity or intolerance to statins.

Previous malignancies unless the patient has been disease-free for 5 or more years prior to study entry 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.

Enrollment: • About 1740 men and women from different cancer centers will take part in this study.

Benefits:

Taking part in this study may or may not make your health better.  While doctors hope that rosuvastatin will be useful in cancer prevention, there is no proof of this yet.  A possible benefit may be the prevention of colon or rectal polyps that could lead to cancer.  We hope the information learned from this study will help patients in the future who are at increased risk for developing polyps of the colon and rectum.

Contact:

These clinical trial overviews are intended to provide a brief overview of the clinical trial. To help determine whether the trial is appropriate for you, the major eligibility criteria are listed above. To obtain more information on the eligibility and the treatment plan, please contact our Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353.

Created: Jul 5, 2012

Updated: Jan 18, 2013