Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

406

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline

Completed

Started Mar 2010

Geographic Reach

2 countries

587 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

November 10, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed

4 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed

8.5 years until next milestone

Results Posted

Study results publicly available

August 16, 2023

Completed

Last Updated

August 16, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

November 10, 2009

Results QC Date

October 4, 2021

Last Update Submit

July 27, 2023

Conditions

Colorectal Cancer Precancerous Condition

Keywords

adenomatous polypstage I colon cancerstage II colon canceradenocarcinoma of the colon

Outcome Measures

Primary Outcomes (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
Up to 4.8 years

Secondary Outcomes (8)

Size of Colorectal Adenomas, Including Advanced Adenomas
Up to 4.8 years
Disease-free Survival
Up to 4.8 years
Overall Survival (OS)
Up to 4.8 years
Recurrence-free Interval (RFI)
Up to 4.8 years
Second Non-colorectal Primary Cancer-free Interval
Up to 4.8 years
+3 more secondary outcomes

Study Arms (2)

Group 1: placebo

PLACEBO COMPARATOR

Patients receive oral placebo once daily for 5 years.

Other: placebo

Group 2: rosuvastatin

EXPERIMENTAL

Patients receive oral rosuvastatin once daily for 5 years.

Drug: rosuvastatin

Interventions

rosuvastatinDRUG

Also known as: Crestor

Group 2: rosuvastatin

placeboOTHER

Group 1: placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NSABP Foundation Inclead
National Cancer Institute (NCI)collaborator

Study Sites (587)

Regional Medical Center

Anniston, Alabama, 36207, United States

Location

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, 72903, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Kaiser Permanente Medical Center - Anaheim/Orange County

Anaheim, California, 92807, United States

Location

Kaiser Permanente - Deer Valley

Antioch, California, 94531, United States

Location

Kaiser Permanente Medical Center - Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente Medical Center - Bellflower

Bellflower, California, 90706, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Kaiser Permanente Medical Center - Fontana

Fontana, California, 92335, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

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

Fullerton, California, 92835, United States

Location

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Kaiser Permanente Medical Center - Harbor City

Harbor City, California, 90710, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Kaiser Permanente - Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Kaiser Foundation Hospital - West Los Angeles

Los Angeles, California, 90034, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Camino Medical Group - Treatment Center

Mountain View, California, 94040, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus