Statin Polyp Prevention Trial in Patients With Resected Colon Cancer
Statin Polyp Prevention Trial in Patients With Resected Colon Cancer
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to family history of a first-degree relative with colorectal cancer (yes vs no), intended aspirin dose (none vs 81 mg vs 325 mg), and adjuvant therapy for colon cancer (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients may complete a quality-of-life questionnaire at baseline and at 6, 12, 36, 60, and 84 months.
Tumor tissue, serum, and blood samples may be collected periodically for biomarker and other analyses.
After completion of study treatment, patients are followed up periodically for up to 2 years.
Inclusion Criteria
Exclusion Criteria
Fort Smith, Arkansas 72903, United States
Little Rock, Arkansas 72205, United States
Fullerton, California 92835, United States
Ontario, California 91761, United States
Rancho Mirage, California 92270, United States
San Diego, California 92120, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Grand Junction, Colorado 81502, United States
Farmington, Connecticut 06360-2875, United States
Hartford, Connecticut 06102-5037, United States
Hartford, Connecticut 06105, United States
Stamford, Connecticut 06904, United States
Washington D.C., District of Columbia 20002, United States
Washington D.C., District of Columbia 20010, United States
Fort Lauderdale, Florida 33308, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83706, United States
Moline, Illinois 61265, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Louisville, Kentucky 40202, United States
Shreveport, Louisiana 71130-3932, United States
Baltimore, Maryland 21237, United States
Largo, Maryland 20774, United States
Fall River, Massachusetts 02721, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Concord, New Hampshire 03301, United States
Flemington, New Jersey 08822, United States
Marlton, New Jersey 08053, United States
Toms River, New Jersey 08755, United States
Vineland, New Jersey 08360, United States
Voorhees Township, New Jersey 08043, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Lake Success, New York 11042, United States
Manhasset, New York 11030, United States
Middletown, New York 10940-4199, United States
Staten Island, New York 10305, United States
Burlington, North Carolina 27216, United States
Charlotte, North Carolina 28232-2861, United States
Greensboro, North Carolina 27403-1198, United States
Pinehurst, North Carolina 28374, United States
Winston-Salem, North Carolina 27103, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Portland, Oregon 97213-2967, United States
Allentown, Pennsylvania 18105, United States
Drexel Hill, Pennsylvania 19026, United States
DuBois, Pennsylvania 15801, United States
East Stroudsburg, Pennsylvania 18301, United States
Harrisburg, Pennsylvania 17110-2098, United States
Philadelphia, Pennsylvania 19107-5541, United States
Pittsburgh, Pennsylvania 15224-1791, United States
Scranton, Pennsylvania 18510, United States
Upland, Pennsylvania 19013, United States
Wilkes-Barre, Pennsylvania 18711, United States
Williamsport, Pennsylvania 17701, United States
Charleston, South Carolina 29425, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Kingsport, Tennessee 37662, United States
San Antonio, Texas 78229-3900, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Walla Walla, Washington 99362, United States
Huntington, West Virginia 25702, United States
Green Bay, Wisconsin 54301-3526, United States
Manitowoc, Wisconsin 54221-1450, United States
Wausau, Wisconsin 54401, United States