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Statin Polyp Prevention Trial in Patients With Resected Colon Cancer

Phase 3
18 Years
Open (Enrolling)
Colorectal Cancer, Precancerous Condition

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Trial Information

Statin Polyp Prevention Trial in Patients With Resected Colon Cancer



- 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.


- 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

- 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

- 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.

- Arm I: Patients receive oral rosuvastatin once daily for 5 years.

- Arm II: Patients receive oral placebo 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

After completion of study treatment, patients are followed up periodically for up to 2

Inclusion Criteria


- 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

- 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)


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Occurrence of ≥ 1 adenomatous polyp of the colon or rectum, metachronous colorectal carcinoma, or colon cancer recurrence (APMC+R) during a 5-year follow-up period

Safety Issue:


Principal Investigator

Bruce M. Boman, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Surgical Adjuvant Breast and Bowel Project (NSABP)



Study ID:




Start Date:

March 2010

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Precancerous Condition
  • adenomatous polyp
  • stage I colon cancer
  • stage II colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Precancerous Conditions



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Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
Michiana Hematology Oncology PC - Niles Niles, Michigan  49120
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
St. Luke's Hospital Cancer Care Center Duluth, Minnesota  55805
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
St. Joseph Medical Center Kansas City, Missouri  64114
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Frederick R. and Betty M. Smith Cancer Treatment Center Sparta, New Jersey  07871
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Christ Hospital Cancer Center Cincinnati, Ohio  45219
Grant Medical Center Cancer Care Columbus, Ohio  43215
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Cancer Care Associates - Mercy Campus Oklahoma City, Oklahoma  73120
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
Susquehanna Cancer Center at Divine Providence Hospital Williamsport, Pennsylvania  17701
York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
St. Joseph Cancer Center Bellingham, Washington  98225
Providence Centralia Hospital Centralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Community Hospital Munster, Indiana  46321
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany, Georgia  31702
Seton Shivers Cancer Program at Brackenridge Hospital Austin, Texas  78701
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Union Hospital of Cecil County Elkton MD, Maryland  21921
Kinston Medical Specialists Kinston, North Carolina  28501
Greenville Hospital Cancer Center Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
St. Vincent's Medical Center Jacksonville, Florida  32203
Resurrection Medical Center Chicago, Illinois  60631
Sherman Hospital Elgin, Illinois  60120-2198
Frederick Memorial Hospital Regional Cancer Therapy Center Frederick, Maryland  21701
Memorial Healthcare Owosso, Michigan  48867
Phelps County Regional Medical Center Rolla, Missouri  65401
McLeod Regional Medical Center Florence, South Carolina  29501
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Lakes Region General Hospital Laconia, New Hampshire  03246
PinnacleHealth Regional Cancer Center at Polyclinic Hospital Harrisburg, Pennsylvania  17105
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Louisville Oncology at Norton Cancer Institute - Louisville Louisville, Kentucky  40202
Galesburg Clinic, PC Galesburg, Illinois  61401
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Berkshire Hematology Oncology, PC Pittsfield, Massachusetts  01201
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Alexian Brothers Radiation Oncology Elk Grove Village, Illinois  60007
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Mercy General Health Partners Muskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Trinity CancerCare Center Minot, North Dakota  58701
Riddle Memorial Hospital Cancer Center Media, Pennsylvania  19063
AnMed Cancer Center Anderson, South Carolina  29621
Fountain Valley, California  92708
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Cleveland Clinic Florida - Weston Weston, Florida  33331
St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington, West Virginia  25702
J. Phillip Citta Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Saint Mary's Regional Medical Center Reno, Nevada  89503
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Immanuel St. Joseph's Mankato, Minnesota  56002
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Self Regional Cancer Center at Self Regional Medical Center Greenwood, South Carolina  29646
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Camino Medical Group - Treatment Center Mountain View, California  94040
Princeton Community Hospital Princeton, West Virginia  24740
Virginia K. Crosson Cancer Center at St. Jude Medical Center Fullerton, California  92835
Kaiser Permanente Capital Area Medical Group - Shady Grove Facility Rockville, Maryland  20850
Ephrata Cancer Center at Ephrata Community Hospital Ephrata, Pennsylvania  17522
St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla, Washington  99362
Richard G. Laube Cancer Center at ACMH Kittanning, Pennsylvania  16201
Radiation Oncology Associates - Reno Reno, Nevada  89509
Kaiser Permanente - Division of Research - Oakland Oakland, California  94611
Kaiser Permanente Medical Center - Rancho Cordova Rancho Cordova, California  95670
Rohnert Park Cancer Center Rohnert Park, California  94928
South Sacramento Cancer Center Sacramento, California  95823
CCOP - Kansas City Prairie Village, Kansas  66208
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo, Maryland  20774
Kaiser Permanente Medical Center - Fair Oaks Fairfax, Virginia  22033
Langlade Memorial Hospital Antigo, Wisconsin  54409
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Southeast Cancer Center Cape Girardeau, Missouri  63703
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141
Cancer Care Associates - Norman Norman, Oklahoma  73071
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Mercy Hospital Portland, Maine  04101
United Hospital Center Clarksburg, West Virginia  26301
Highland Clinic Shreveport, Louisiana  71105
Drs Gurtler Brinz and Russo APMC-Metairie Oncologists Metairie, Louisiana  70006
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Celilo Cancer Center at Mid-Columbia Medical Center The Dalles, Oregon  97058
Adams Cancer Center Gettysburg, Pennsylvania  17325
Cherry Tree Cancer Center Hanover, Pennsylvania  17331
Kaiser Permanente at Capitol Hill Medical Center Washington, District of Columbia  20002
Kaiser Permanente at Woodlawn Medical Center Baltimore, Maryland  21244
Kaiser Permanente Medical Center - Vacaville Vacaville, California  95688
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Mercy Cancer Center - West Lakes Clive, Iowa  50325
Methodist West Hospital West Des Moines, Iowa  50266-7700
Kaiser Permanente Fresno Medical Center Fresno, California  93720
Olympic Medical Cancer Center Sequim, Washington  98382
CHRISTUS Cabrini Cancer Center Alexandria, Louisiana  71301