AzTrials
AzTrials

Colorectal CancerPhase 3NCT01011478

Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery

A Phase 3 study testing rosuvastatin in people with Colorectal Cancer and Precancerous Condition, run by NSABP Foundation Inc at 587 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Precancerous Condition
What is being tested?
rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
587 sitesin 2 countries
Study dates
Mar 2010to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

587 sites in 2 countries.

303 sites in 2 countries

United States300 sites

  • Oncology Services of Aberdeen

    Aberdeen, South Dakota, 57401

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Hematology Oncology Associates, PC

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • CHRISTUS Cabrini Cancer Center

    Alexandria, Louisiana, 71301

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • American Fork Hospital

    American Fork, Utah, 84003

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Kaiser Permanente Medical Center - Anaheim/Orange County

    Anaheim, California, 92807

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Regional Medical Center

    Anniston, Alabama, 36207

  • Langlade Memorial Hospital

    Antigo, Wisconsin, 54409

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • MBCCOP - Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60504

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Kaiser Permanente Medical Center - Baldwin Park

    Baldwin Park, California, 91706

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Kaiser Permanente at Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • CancerCare of Maine at Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Overlake Cancer Center at Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Kaiser Permanente Medical Center - Bellflower

    Bellflower, California, 90706

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Study site

    Bettendorf, Iowa, 52722

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59102

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Illinois CancerCare - Bloomington

    Bloomington, Illinois, 61701

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Central Care Cancer Center at Carrie J. Babb Cancer Center

    Bolivar, Missouri, 65613

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts, 01805

  • Alamance Cancer Center at Alamance Regional Medical Center

    Burlington, North Carolina, 27216

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Graham Hospital

    Canton, Illinois, 61520

  • Illinois CancerCare - Canton

    Canton, Illinois, 61520

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Cancer Center at Aultman Hospital

    Canton, Ohio, 44710-1799

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Illinois CancerCare - Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Providence Centralia Hospital

    Centralia, Washington, 98531-9027

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • United Hospital Center

    Clarksburg, West Virginia, 26301

  • Medical Oncology and Hematology Associates - West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center - West Lakes

    Clive, Iowa, 50325

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

    Concord, New Hampshire, 03301

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80222

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Kent General Hospital

    Dover, Delaware, 19901

  • Doylestown Hospital Cancer Center

    Doylestown, Pennsylvania, 18901

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center

    DuBois, Pennsylvania, 15801

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Luke's Hospital Cancer Care Center

    Duluth, Minnesota, 55805

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Shore Regional Cancer Center at Memorial Hospital - Easton

    Easton, Maryland, 21601

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Sherman Hospital

    Elgin, Illinois, 60123

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Ephrata Cancer Center at Ephrata Community Hospital

    Ephrata, Pennsylvania, 17522

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare - Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Center for Cancer Care at Exeter Hospital

    Exeter, New Hampshire, 03833

  • Kaiser Permanente Medical Center - Fair Oaks

    Fairfax, Virginia, 22033

  • North Bay Cancer Center

    Fairfield, California, 94533

  • Southcoast Center for Cancer Care

    Fairhaven, Massachusetts, 02719

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • Dakota Cancer Institute at Dakota Clinic - South University

    Fargo, North Dakota, 58103

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Kaiser Permanente Medical Center - Fontana

    Fontana, California, 92335

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Valley Medical Oncology

    Fremont, California, 94538

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Virginia K. Crosson Cancer Center at St. Jude Medical Center

    Fullerton, California, 92835

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Kaiser Permanente - Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Illinois CancerCare - Galesburg

    Galesburg, Illinois, 61401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Glendale Memorial Hospital Comprehensive Cancer Center

    Glendale, California, 91204

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota, 58201

  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301-3526

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas - Grove Commons

    Greenville, South Carolina, 29605

  • Greenville Hospital Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Bendheim Cancer Center at Greenwich Hospital

    Greenwich, Connecticut, 06830

  • Cancer Centers of the Carolinas - Greer Medical Oncology

    Greer, South Carolina, 29650

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Kaiser Permanente Medical Center - Harbor City

    Harbor City, California, 90710

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17110-2098

  • Helen and Harry Gray Cancer Center at Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Illinois CancerCare - Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • New Hampshire Oncology - Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Kaiser Permanente - Irvine

    Irvine, California, 92618

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Mercy Regional Cancer Center

    Janesville, Wisconsin, 53547

  • Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology Oncology Associates, Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Illinois CancerCare - Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Kinston Medical Specialists

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Kaiser Permanente - Lafayette

    Lafayette, Colorado, 80026

  • Monter Cancer Center of the North Shore-LIJ Health System

    Lake Success, New York, 11042

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78045

  • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility

    Largo, Maryland, 20774

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • St. Joseph Regional Medical Center

    Lewiston, Idaho, 83501

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Parvin Radiation Oncology

    Liberty, Missouri, 64068

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska, 68510

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Study site

    Little Rock, Arkansas, 72205

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • St. Barnabas Medical Center Cancer Center

    Livingston, New Jersey, 07039

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

Other trials in United States

Canada3 sites

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Royal Victoria Hospital - Montreal

    Montreal, Quebec, H3A 1A1

  • Hopital du Saint-Sacrement - Quebec

    Québec, Quebec, G1S 4L8

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the effect of rosuvastatin vs placebo on the 5-year occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) in patients with resected stage I or II colon cancer.

Secondary

  • To determine whether the effect of rosuvastatin vs placebo is of the same magnitude in patients taking aspirin (regardless of dose) compared to patients not taking aspirin.
  • To determine whether taking aspirin (regardless of dose) vs no aspirin will decrease the occurrence or APMC+R and, if there is an effect, to explore the relationship to dose.
  • To determine the effect of rosuvastatin in patients with familial colorectal cancer.
  • To determine the effect of rosuvastatin in patients with microsatellite unstable tumors (i.e., tumors displaying loss of MLH1 or MSH2 expression by IHC).
  • To determine the relationship between rosuvastatin therapy and features of colorectal adenomas as well as the size and number of colorectal adenomas.
  • To compare the time to APMC+R in patients treated with rosuvastatin vs placebo.
  • To compare the disease-free survival of patients treated with rosuvastatin vs placebo.
  • To compare the overall survival of patients treated with rosuvastatin vs placebo.
  • To compare the rate of recurrence of colon cancer in patients treated with rosuvastatin vs placebo.
  • To compare the rate of second non-colorectal primary cancers in patients treated with rosuvastatin vs placebo.
  • To determine the effect of rosuvastatin on health-related quality of life, global quality of life, and self-reported symptoms.
  • To compare the incidence and severity of adverse events associated with rosuvastatin vs placebo.
  • To assess relevant tumor and blood markers that may affect the metabolism, activity, or effect of the study drugs, such as HMG-CoA reductase, UGT1A6, P450-2C9, PTGS2 (COX-2), and other possible markers.

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.

  • Group 1: Patients receive oral placebo once daily for 5 years.
  • Group 2: Patients receive oral rosuvastatin once daily for 5 years.

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.

Being tested
rosuvastatin, placebo
Keywords
adenomatous polyp, stage I colon cancer, stage II colon cancer, adenocarcinoma of the colon
Medical subject headings
Colorectal Neoplasms, Precancerous Conditions, Adenomatous Polyps, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01011478
Study groupRoleWhat they receive
Group 1: placeboPlacebo comparatorPatients receive oral placebo once daily for 5 years.
Receives: Other: placebo
Group 2: rosuvastatinExperimentalPatients receive oral rosuvastatin once daily for 5 years.
Receives: Drug: rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R)

    Percentage of patients with occurrence of APMC+R event. APMC+R events include at least one adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence

    Measured: Up to 4.8 years

Secondary outcomes (8)

  1. Size of Colorectal Adenomas, Including Advanced Adenomas

    The histologic size (diameter of adenoma into the wall of the colon; as per AJCC staging) of the largest adenoma among patients who have at least one adenoma detected. If histologic size was not available, the endoscopic size was provided.

    Measured: Up to 4.8 years

  2. Disease-free Survival

    Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause)

    Measured: Up to 4.8 years

  3. Overall Survival (OS)

    Number of patients with the OS event (death from any cause)

    Measured: Up to 4.8 years

  4. Recurrence-free Interval (RFI)

    Number of patients with the RFI event (First recurrence of colon cancer)

    Measured: Up to 4.8 years

  5. Second Non-colorectal Primary Cancer-free Interval

    Number of patients with the first occurrence of non-colorectal primary cancer

    Measured: Up to 4.8 years

  6. Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist

    Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status.

    Measured: 12-month time point

  7. Toxicity Assessed by Adverse Events

    Percentage of patients with at least one grade 2 or higher adverse event reported.

    Measured: Up to 4.8 years

  8. Measurements of Relevant Tumor and Blood Markers

    This study terminated early. Data on samples was not collected, the relevant analyses were not performed.

    Measured: At randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2009 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2014
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011478
Sponsor's protocol ID
NSABP-P-5
Other IDs
NSABP P-5, NCI-2011-09183
Status last verified
Jul 2023
First submitted
10 Nov 2009
Last updated
16 Aug 2023
Data monitoring committee
Yes

Publications

  • Boman BM, Bandos H, Wickerham DL, et al.: Statin polyp prevention trial in patients with resected colon cancer: NSABP protocol P-5. [Abstract] J Clin Oncol 30 (Suppl 15): A-TPS1615, 2012.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rosuvastatin in people with Colorectal Cancer and Precancerous Condition, run by NSABP Foundation Inc at 587 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 587 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R) (time frame: Up to 4.8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01011478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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