NCT01606124

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 28, 2017

Completed
Last Updated

October 27, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

May 23, 2012

Results QC Date

August 28, 2017

Last Update Submit

September 27, 2017

Conditions

Advanced Colorectal AdenomasAdenocarcinoma of the ColonStage I Colon CancerStage II Colon CancerStage III Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months

    The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.

    6 months

Secondary Outcomes (1)

  • Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months

    6 months

Study Arms (2)

Arm I (Green Tea Catechin Extract)

EXPERIMENTAL

Patients receive Polyphenon E PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.

Drug: defined green tea catechin extractOther: questionnaire administrationOther: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.

Other: placeboOther: questionnaire administrationOther: laboratory biomarker analysis

Interventions

defined green tea catechin extractDRUG

Given PO

Also known as: Polyphenon E
Arm I (Green Tea Catechin Extract)
placeboOTHER

Given PO

Also known as: PLCB
Arm II (placebo)
questionnaire administrationOTHER

Ancillary studies

Arm I (Green Tea Catechin Extract)Arm II (placebo)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (Green Tea Catechin Extract)Arm II (placebo)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois

Chicago, Illinois, 60612, United States

Location

Hines Veteran's Administration Hospital

Hines, Illinois, 60612, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Frank A. Sinicrope, M.D.
Organization
Mayo Clinic
sinicrope.frank@mayo.edu
507-284-2511

Study Officials

  • Frank Sinicrope

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

June 1, 2012

Primary Completion

May 21, 2015

Study Completion

May 21, 2015

Last Updated

October 27, 2017

Results First Posted

September 28, 2017

Record last verified: 2017-05

Locations

US(3)