A Phase II Trial of Green Tea Extract in the Treatment of Androgen-Independent Metastatic Prostate Cancer
OBJECTIVES: I. Determine the effectiveness and toxicity of green tea extract in patients
with androgen-independent metastatic prostate cancer. II. Determine the response rate and
response duration in patients treated with this regimen. III. Determine whether a decline in
prostate-specific antigen (PSA) coincides with evidence of disease regression in these
patients.
OUTLINE: Patients receive oral green tea extract six times daily for 4 months. Patients with
a 50% decline in PSA, complete or partial response, or stable disease after 4 months
continue treatment in the absence of disease progression or unacceptable toxicity. Patients
with disease progression after 4 months receive no further treatment. Patients are followed
every 3 months for 5 years or until disease progression. If disease progression, patients
are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 15-44 patients will be accrued for this study within 1.5
years.
Interventional
Primary Purpose: Treatment
Aminah Jatoi, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067842
NCT00005828
December 2000
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Medcenter One Health System | Bismarck, North Dakota 58501 |