Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

Cervical Cancer Clinical Trial

Official title:

A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303823
• Other study ID #: NCI-2009-00893
• Secondary ID: NCI-2009-00893CD
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2006
• Last updated: April 14, 2015
• Start date: September 2005
• Est. completion date: February 2011

Study information

• Verified date: April 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.

Description:

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

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

TERTIARY OBJECTIVES:

I. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 1
• Human Papilloma Virus Infection
• Neoplasms
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms
• Virus Diseases

Intervention

Drug:
• placebo
Given orally

Dietary Supplement:
• defined green tea catechin extract
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Arizona Cancer Center - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease		4 months	No
Primary	Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia		4 months	No
Primary	No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia		4 months	No
Primary	Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer		4 months	No