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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Frank Sinicrope, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions