Epigallocatechin Gallate in Treating Patients with Colorectal Cancer That Can Be Removed by Surgery
- Cytologically or histologically confirmed of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer
- Eastern Cooperative Oncology Group (COG) 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 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
- Granulocyte count > 1000/mm^3 (within 7 days prior to cycle 1 day 1)
- Platelet count > 50,000/mm^3 (within 7 days prior to cycle 1 day 1)
- Hemoglobin > 7 g/dL (within 7 days prior to cycle 1 day 1)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 7 days prior to cycle 1 day 1)
- Albumin > 2.8 g/dl (within 7 days prior to cycle 1 day 1)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN (within 7 days prior to cycle 1 day 1)
- Serum creatinine < 2 x ULN (within 7 days prior to cycle 1 day 1)
- Patients receiving prior chemotherapy or chemoradiation for colorectal cancer (i.e., 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 intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with nasogastric (NG)-tube, jejunostomy feeding (J)-tube, or gastrostomy (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
- 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
I. To evaluate the preventive effects of epigallocatechin gallate (EGCG) on colonic tissue in patients with resected colorectal cancer when compared to patients on observation.
I. To determine the safety of EGCG in patients with resected colorectal cancer when compared to observation.
II. To assess whether EGCG has efficacy against colorectal lesions with respect to high-grade dysplasia, adenomas with villous features, and second colorectal cancers on follow-up colonoscopy at 1 year.
III. To determine effect of EGCG on tumor biomarkers, cellular senescence and inflammatory markers (cytokines) when compared to observation. (Exploratory)
PART I (OPTIONAL): Patients undergo standard of care surgery.
PART II: Patients are randomized to 1 of 2 arms.
ARM I: Within 4-12 weeks after surgery, patients receive epigallocatechin gallate orally (PO) twice daily (BID) on days 1-30. Cycles repeat every 30 days for 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo standard of care observation for 1 year.
After completion of study treatment, patients are followed up for 6 months.
Trial Phase Phase O
Trial Type Prevention
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Sukeshi Patel Arora
- Primary ID CTMS# 16-0085
- Secondary IDs NCI-2016-01852, HSC20160446H
- Clinicaltrials.gov ID NCT02891538