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A Phase II Trial of Polyphenon E for Cervical Cancer Prevention


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

A Phase II Trial of Polyphenon E for Cervical Cancer Prevention


OBJECTIVES:

Primary

- Assess the effect of green tea extract (Polyphenon E^®) in patients with human
papillomavirus (HPV) expression and low-grade cervical intraepithelial neoplasia (CIN
1) in a pre- and post-treatment setting.

Secondary

- Compare the toxicity of green tea extract vs placebo among patients with CIN 1.

Tertiary

- Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical
chemoprevention studies.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral green tea extract (Polyphenon E^®) once daily for 16 weeks
in the absence of unacceptable toxicity.

- Arm II: Patients receive oral placebo once daily for 16 weeks in the absence of
unacceptable toxicity.

After completion of study treatment, patients are followed for 2 weeks.

PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic
human papillomavirus (HPV) positivity

- At increased risk for developing cervical cancer due to ≥ 1 of the following criteria
(documented 6-12 months ago)*:

- Positive oncogenic HPV on DNA hybrid capture

- Low-grade squamous intraepithelial lesion cytology

- Histopathologically documented CIN 1 on cervical biopsy NOTE: *Patients must now
have current CIN 1 by histology or colposcopy AND HPV positivity

- Cervical dysplasia by colposcopy OR positive biopsy

- No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical
biopsy or endocervical curettage

PATIENT CHARACTERISTICS:

- ECOG performance status < 2

- Total bilirubin < 2 times upper limit of normal (ULN)

- AST < 2 times ULN

- ALT normal

- Creatinine < 2.0 mg/dL

- Able and willing to return to clinic for study visits once every 4 weeks for the
duration of the study

- No history of allergic reaction to tea or related dietary products

- No HIV positive patients (or AIDS/HIV-associated complex)

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection other than HPV

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situation that would limit compliance with study
requirements

- No history of any cancer except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No regular intake of 6 or more servings of tea per week within 1 month prior to study
entry

- No treatment for genital condyloma within 30 days prior to study entry

- No prior pelvic irradiation

- No concurrent tea (green, black, or oolong) or tea-derived products

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Complete Response - Clearance of Oncogenic HPV and Complete Colposcopic, Histologic and Cytologic Clearance of Disease

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Francisco A. R. Garcia, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000458081

NCT ID:

NCT00303823

Start Date:

November 2005

Completion Date:

November 2010

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • human papilloma virus infection
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Uterine Cervical Dysplasia
  • Carcinoma in Situ

Name

Location

Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260