Clinical Trial TitleStudy to determine if subjects with colorectal cancers will benefit from eflornithine and sulindac.
Clinical Trial Protocol Description:
A double blind placebo-controlled trial of eflornithine and sulindac to prevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon or rectal cancer, phase III – preventing adenomas of the colon with eflornithine and sulindac (Paces).
Study for eflornithine and sulindac for subjects with stage 0-III colon or rectal cancers and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a history of stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy. (95) Adjuvant chemotherapy and RT treatment must have been completed at least 30 days prior to registration.
- Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection). The definition of resection does not include endomucosal resection (EMR). Patients that have received total proctocolectomy are ineligible.
- Are registered between 180 days and 456 days (inclusive) of primary resection. Patients must show no evidence of disease (NED) based on post-operative colonoscopy (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration) and CT scans* of chest, abdomen and pelvis (performed at least 180 days after the colon resection date or at least 120 days after the rectal resection date and prior to registration). Patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed.
*CT scan is for high risk patients, as per NCCN guidelines and at the discretion of the treating physician.
Note: MRI evaluation is an acceptable alternative to CT scans for eligibility purposes.
You will be excluded from the study if any of the following criteria apply to you:
- Have cardiovascular risk factors including unstable angina, history of documented myocardial infarction or cerebrovascular accident, coronary artery bypass surgery, or New York Heart Association Class III or IV heart failure. Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C less or equal to 190 mg/dL or triglycerides greater or equal to 500mg/ dL) within the last 3 years prior to registration or uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg) within 28 days prior to registration.
- Have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease.
- Have known hypersensitivity to eflornithine or sulindac or the excipients byproducts. Patients must not have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAID.
- Have documented history of gastric/duodenal ulcer within the last 12 months. Participant must not currently be on treatment for gastric/duodenal ulcer or be experiencing symptoms at study entry. Patients with gastroesophageal reflux disease (GERD) are eligible, however, and these patients may receive over-the-counter histamine-2 (H2) antagonists, proton-pump inhibitors, or other prescription-based treatment for GERD.
This is a partial list of inclusion and exclusion criteria.