Epigallocatechin Gallate in Treating Patients with Colorectal Cancer That Can Be Removed by Surgery

Status: Active

Description

This randomized pilot clinical trial studies how well epigallocatechin gallate works in treating patients with colorectal cancer that can be removed by surgery. Epigallocatechin gallate is a dietary supplement that may help prevent colorectal cancer.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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
  • Platelet count > 50,000/mm^3
  • Hemoglobin > 7 g/dL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Albumin > 2.8 g/dl
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x 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 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; 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; 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

Locations & Contacts

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: Active
Contact: Sukeshi Patel Arora
Phone: 210-450-1015
Email: patels3@uthscsa.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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)

OUTLINE:

PART I: 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. Courses 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 & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

Principal Investigator
Sukeshi Patel Arora

Trial IDs

Primary ID CTMS# 16-0085
Secondary IDs NCI-2016-01852, HSC20160446H
Clinicaltrials.gov ID NCT02891538