Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients
Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients
This will be a randomized, controlled pilot trial of patients with histological documentation
 of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any
 treatments for cancer. If patient is a candidate for surgical resection, with no planned
 neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be
 consented prior to surgery.
Part 1: Blood draw prior to surgery, followed by surgical resection, and surgical pathologic
 specimen will be archived. After surgery, patient will be seen in 4-12 weeks to determine if
 adjuvant chemotherapy is indicated, in which case patient will receive adjuvant therapy. At
 this visit a blood draw will be done.

 Part 2: If the patient is stage 0/1/2 and no plan for adjuvant treatments, then the patient
 will be randomized in a 2:1 manner to EGCG 900 mg daily vs observation (standard of care) for
 1 year. Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and
 take EGCG 450 mg PO twice a day. Blood draw will be done at 0, 3, 6, 9, 12, 15, 18 months.
 Colonoscopy will be done at 1 year from diagnosis, at which time normal colonic tissue
 biopsies as well as any resected polyps will be collected.
Inclusion Criteria:

 -  Cytologically or histologically confirmed of primary colon or rectal adenocarcinoma
 with resectable cancer, who have not received any treatments for cancer.

 -  Age 18 years and above

 -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

 -  The patient is a candidate for surgical resection, with no planned neoadjuvant
 chemotherapy, and there is a planned surgery for the primary colorectal cancer cancer
 or the patient had recent resection of the primary colorectal cancer. .

 -  For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile
 (absence of ovaries and/or uterus): agreement to use two adequate methods of
 contraception. For men: agreement to use a barrier method of contraception during the
 treatment period

 -  Hematologic, Biochemical, and Organ Function within 7 days prior to Cycle 1 Day 1:
 Granulocyte count > 1000/mm3, Platelet count > 50,000/ mm3, Hemoglobin > 7 g/dL; Total
 bilirubin < 1.5xULN; Albumin > 2.8g/dl; aspartate aminotransferase (AST) (SGOT) and
 alanine aminotransferase (ALT) (SGPT) </=2.5 x upper limit of normal (ULN); Serum
 creatinine< 2 x ULN

 Exclusion Criteria:

 -  Patients receiving prior chemotherapy or chemoradiation for colorectal cancer (ie,
 neoadjuvant chemoradiation for stage II or III rectal cancer).

 -  Known diagnosis of stage III colon or rectal cancer will be excluded from the study.

 -  Patients with metastatic disease.

 -  Patients may not be receiving any other investigational agents.

 -  History of allergic reactions attributed to compounds of similar chemical or biologic
 composition to green tea or EGCG.

 -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
 infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
 arrhythmia, or psychiatric illness/social situations that would limit compliance with
 study requirements

 -  Gastrointestinal tract disease resulting in an inability to take oral medication or a
 requirement for IV alimentation, prior surgical procedures affecting absorption, or
 active peptic ulcer disease. Patients with nasogastric tube (NG-tube), J-tube, or
 G-tube will not be allowed to participate.

 -  Pregnant women are excluded from this study because of unknown effects of EGCG on
 teratogenic or abortifacient effects. For this reason, women of childbearing potential
 and men must also agree to use adequate contraception (hormonal or barrier method of
 birth control) prior to study entry and for the duration of study participation.

 -  Should a woman become pregnant or suspect she is pregnant while participating in this
 study, she should inform her treating physician immediately. Because there is an
 unknown but potential risk for adverse events in nursing infants secondary to
 treatment of the mother with EGCG, breastfeeding should be discontinued.

 -  Informed Consent - No study specific procedures will be performed without a written
 and signed informed consent document. Patients who do not demonstrate the ability to
 understand or the willingness to sign the written informed consent document will be
 excluded from study entry.