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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Complete Response - Clearance of Oncogenic HPV and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
4 months
No
Francisco A. R. Garcia, MD, MPH
Study Chair
University of Arizona
United States: Food and Drug Administration
CDR0000458081
NCT00303823
November 2005
November 2010
Name | Location |
---|---|
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |