Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer

Inclusion Criteria:

Current or prior advanced adenomas. Participants with advanced adenomas are defined as participants who have polyps >= 1 cm, who have tubulovillous adenomas (25-75 percent villous features), who have villous adenomas (>75 percent villous), or who have severe dysplasia
Prior curatively resected Tumor, Node, Metastasis (TNM) stage II and III colon cancer >= 3 years out from treatment by surgery with/without adjuvant chemotherapy; NOTE: patients with stage I (T1,2 N0) colon cancer treated by endoscopic or surgical therapy are eligible at anytime after such therapy; patients with prior stage IV disease must be >= 5 years status post surgical resection of all metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Ability to understand and the willingness to sign a written informed consent document
Willingness to discontinue regular usage of calcium supplements; Exception: multi-vitamin; regular use defined as a frequency of 7 consecutive days for > 3 weeks
Willingness to provide mandatory tissue and blood for protocol specified research; residual tissue and/or blood may be used for future research Negative pregnancy test =< 7 days prior to registration/randomization
Hemoglobin (Hgb) >= 12.0 g/dL (women), >= 13.5 g/dL (men) at Mayo Clinic or within normal limits at an outside laboratory
Platelet count >= 100,000/ul
White blood cells (WBC) >= 3,000/ul
Alanine aminotransferase (ALT) within institutional limits of normal
Alkaline phosphatase within institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) within institutional limits of normal
Total bilirubin within institutional limits of normal
Serum calcium =< institutional ULN
Serum creatinine =< 1.5 x institutional ULN
>= 5 rectal ACF detected by chromoendoscopy =< 45 days prior to registration/randomization
Endoscopy =< 45 days prior to registration/randomization; Note: All adenomas or polyps will be removed according to institutional standards of care, and the cecum must visualized; this may be done at the same time as the chromoendoscopy

Exclusion Criteria:

Any history of rectal cancer; Exception: transanal excision without radiation
Known diagnosis of colon heritable cancer syndrome (Familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Inability to swallow capsules
Bleeding diathesis

Any invasive malignancy =< 5 years prior to pre-registration;

Exceptions:
patients with nonmelanoma skin cancers that were treated with simple excisional biopsy or stage I (T1,2 N0)
colon cancer treated by endoscopic therapy or surgery are eligible
History of gastroduodenal ulcers documented =< 1 year
Known inability to participate in the scheduled follow-up tests
Significant medical or psychiatric problems which would make the participant a poor protocol candidate, in the opinion of the treating physician
Total colectomy
Colostomy
History of pelvic or rectal radiation therapy
History of liver disease
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Concomitant corticosteroids or anticoagulants needed on a regular or predictable intermittent basis
Use of non-study investigational agent(s) =< 3 months prior to preregistration
Chemotherapy =< 6 months prior to pre-registration; Note: Topical chemotherapy will be assessed on a case-by-case basis
Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception Note: This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown
Over-the-counter green tea or green tea extract use =< 6 weeks prior to pre-registration; consumption of over the counter green tea extracts or drinking of green tea is not permitted during the treatment portion of this trial
Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) =< 6 weeks prior to pre-registration; regular use of NSAIDs is defined as a frequency of 7 consecutive days (1 week) for > 3 weeks; participant must abstain from regular use of NSAIDs for the duration of the study; Exception: low dose aspirin (81 mg) for those participants who are chronic users of aspirin prior to the beginning of the study
Use of non-study investigational agents while on study