A Phase II Trial of Polyphenon E for Cervical Cancer Prevention
- 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.
- Compare the toxicity of green tea extract vs placebo among patients with CIN 1.
- Evaluate the utility of karyometry as an intermediate endpoint biomarker for cervical
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
After completion of study treatment, patients are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.
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
Francisco A. R. Garcia, MD, MPH
University of Arizona
United States: Food and Drug Administration
|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|