Study on Preventing New Growths and Second Cancers in Patients Previously Treated for Colon or Rectal Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT01349881
This clinical trial is testing whether a combination of two drugs, eflornithine and sulindac, can help reduce the risk of new growths and second primary colorectal cancers in patients who have been treated for early-stage colon or rectal cancer.
Patient Parameters
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Program Overview
The aim of this study is to see if taking eflornithine and sulindac together can lower the chances of developing new colorectal growths or cancers in patients who have already been treated for stages 0 to III colon or rectal cancer. Researchers want to find out if this drug combination is more effective than a placebo in preventing various types of colorectal lesions, including those with high-grade dysplasia, larger adenomas, and multiple adenomas.
Description
The study is designed to evaluate whether the combination of eflornithine (500 mg) and sulindac (150 mg) is effective in preventing new colorectal lesions compared to a placebo. Researchers are particularly interested in seeing if this combination can reduce the occurrence of high-grade dysplasia, adenomas with specific features, larger adenomas, multiple adenomas, and other advanced colorectal events. Participants will be monitored for three years to assess the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Previously treated for Stage 0-III colon or rectal cancer with surgery at least one year ago.
- Recent colonoscopy and CT scans showing no signs of cancer.
- No serious heart conditions or history of heart attack or stroke.
- No uncontrolled high cholesterol or high blood pressure.
- At least 30 days since finishing chemotherapy and radiation therapy.
- Controlled gastroesophageal reflux disease is acceptable.
- Not regularly taking certain medications like corticosteroids, NSAIDs, or blood thinners.
- Able to swallow pills.
- Meet specific blood test requirements.
- Good overall health and 18 years or older.
- Not participating in other cancer treatment trials.
- Willing to donate blood samples for research.
Exclusion Criteria
- Had a large section of the colon removed (more than 40 cm).
- Had mid to low rectal cancer.
- Cancer has returned or spread.
- High risk of heart problems or uncontrolled high blood pressure.
- Planning to have more radiation or chemotherapy.
- Recent or active stomach or duodenal ulcers.
- Family history of certain genetic conditions or inflammatory bowel disease.
- Significant hearing loss.
- Allergic to sulindac or similar medications.
- Serious medical or mental health conditions that could affect study participation.
- History of other cancers unless treated and disease-free for over 5 years.
- Pregnant or breastfeeding women, and those not using effective birth control.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
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