Clinical trial NCT01011478
Conditions: Colorectal Cancer Precancerous Condition
Keywords: adenomatous polyp stage I colon cancer stage II colon cancer adenocarcinoma of the colon
Sponsor: NSABP Foundation Inc
Start date: 2010-03-01; Completion date: 2015-02-01
Enrollment: 406 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

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.

Arms: arm 1: Patients receive oral placebo once daily for 5 years. arm 2: Patients receive oral rosuvastatin once daily for 5 years.
Interventions: intervention 1: rosuvastatin intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: