Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer
Condition: Advanced Colorectal Adenomas; Adenocarcinoma of the Colon; Stage I Colon Cancer; Stage II Colon Cancer; Stage III Colon Cancer
MeSH terms: Colonic Neoplasms; Adenoma
Intervention: defined green tea catechin extract; placebo; questionnaire administration; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Ancillary studies; Correlative studies
Intervention MeSH terms: Epigallocatechin gallate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well Polyphenon E works in treating patients with high-risk
      of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal
      cancer.
    

Eligibility criteria:

        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