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

Sponsors and Collaborators:	University of Arizona National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303823

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: defined green tea catechin extract Drug: placebo	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Epigallocatechin gallate Catechin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	A Phase II Trial of Polyphenon E for Cervical Cancer Prevention

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of green tea extract (Polyphenon E) on human papillomavirus (HPV) expression by Digene hybrid capture oncogenic HPV expression before study and 4 months following study completion [ Designated as safety issue: No ]
Effect of this drug on low grade cervical dysplasia by clinical pathology before study and 4 months following study completion [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity of this drug versus placebo as measured by CTCAE version 3 for 4 months during study [ Designated as safety issue: Yes ]
Utility of karyometry as an intermediate endpoint biomarker by karyometry average nuclear abnormality before study and 4 months following study completion [ Designated as safety issue: No ]

Estimated Enrollment:	176
Study Start Date:	November 2005
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral green tea extract once daily for 16 weeks in the absence of unacceptable toxicity.	Drug: defined green tea catechin extract Given orally
Arm II: Placebo Comparator Patients receive oral placebo once daily for 16 weeks in the absence of unacceptable toxicity.	Drug: placebo Given orally

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303823

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center	Recruiting
Tucson, Arizona, United States, 85724-5024
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008
Maricopa Medical Center	Recruiting
Phoenix, Arizona, United States, 85008
Contact: David L. Greenspan, MD 602-344-5439
United States, North Carolina
Southern Pines Women's Health Center, PC	Recruiting
Southern Pines, North Carolina, United States, 28388-0749
Contact: John W. Byron, MD 910-692-7928

Sponsors and Collaborators

University of Arizona

National Cancer Institute (NCI)

Investigators

Study Chair:

Francisco A. R. Garcia, MD, MPH

University of Arizona

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000458081, UARIZ-UAZ03-1-02, UARIZ-HSC-0540
Study First Received:	March 15, 2006
Last Updated:	November 1, 2008
ClinicalTrials.gov Identifier:	NCT00303823
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 1
human papilloma virus infection

Study placed in the following topic categories:

Virus Diseases
Epigallocatechin gallate
Precancerous Conditions
Cervical intraepithelial neoplasia
Carcinoma in Situ

Papillomavirus Infections
Papilloma
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009