Rosuvastatin in Treating Patients With Stage I or Stage II Colon Cancer That Was Removed By Surgery
- Conditions
- Colorectal CancerPrecancerous Condition
- Interventions
- Other: placebo
- Registration Number
- NCT01011478
- Lead Sponsor
- NSABP Foundation Inc
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: placebo placebo Patients receive oral placebo once daily for 5 years. Group 2: rosuvastatin rosuvastatin Patients receive oral rosuvastatin once daily for 5 years.
- Primary Outcome Measures
Name Time Method Occurrence of ≥ 1 Adenomatous Polyp of the Colon or Rectum, Metachronous Colorectal Carcinoma, or Colon Cancer Recurrence (APMC+R) Up to 4.8 years 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
- Secondary Outcome Measures
Name Time Method Size of Colorectal Adenomas, Including Advanced Adenomas Up to 4.8 years 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.
Disease-free Survival Up to 4.8 years Number of patients with DFS event (colon cancer recurrence, second primary cancer, or death from any cause)
Overall Survival (OS) Up to 4.8 years Number of patients with the OS event (death from any cause)
Recurrence-free Interval (RFI) Up to 4.8 years Number of patients with the RFI event (First recurrence of colon cancer)
Second Non-colorectal Primary Cancer-free Interval Up to 4.8 years Number of patients with the first occurrence of non-colorectal primary cancer
Behavioral and Health Outcomes as Measured by SF-12 Component Scores, Global Quality-of-life Scale, and Symptom Checklist 12-month time point Global Quality-of-life Scale score, ranges from 0 (worst imaginable health status) to 10 (best imaginable health status.
Toxicity Assessed by Adverse Events Up to 4.8 years Percentage of patients with at least one grade 2 or higher adverse event reported.
Measurements of Relevant Tumor and Blood Markers At randomization This study terminated early. Data on samples was not collected, the relevant analyses were not performed.
Trial Locations
- Locations (584)
Regional Medical Center
🇺🇸Anniston, Alabama, United States
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Anaheim/Orange County
🇺🇸Anaheim, California, United States
Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States
Kaiser Permanente Medical Center - Baldwin Park
🇺🇸Baldwin Park, California, United States
Kaiser Permanente Medical Center - Bellflower
🇺🇸Bellflower, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Scroll for more (574 remaining)Regional Medical Center🇺🇸Anniston, Alabama, United States