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A Phase II Trial of Green Tea Extract in the Treatment of Androgen-Independent Metastatic Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Clinically proven androgen-independent metastatic prostate cancer
Radiological, physically palpable, and/or biochemical evidence of progression Increase in
PSA after orchiectomy or hormonal treatment No symptoms directly attributable to
metastatic disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL
Renal: Creatinine no greater than 2 times upper limit of normal Cardiovascular: No
uncontrolled high blood pressure No unstable angina No symptomatic congestive heart
failure No uncontrolled cardiac arrhythmias No myocardial infarction in past 6 months
Other: No other malignancy within the past 5 years except basal cell skin cancer No
uncontrolled diabetes mellitus or inability to tolerate high sugar content of green tea at
discretion of oncologist No other medical or psychiatric conditions that would preclude
study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy
Endocrine therapy: At least 4 weeks since prior flutamide or megestrol At least 6 weeks
since prior longer-acting hormonal agents such as bicalutamide At least 4 weeks since
prior hormonal therapy, except luteinizing hormone- releasing hormone agonist No
concurrent hormonal therapy, including corticosteroids for cancer treatment Radiotherapy:
No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent
investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067842

NCT ID:

NCT00005828

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medcenter One Health SystemBismarck, North Dakota  58501