RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers. PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer recurrent prostate cancer	Drug: green tea extract	Phase II

Further Study Details: 

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 PSA coincides with evidence of disease regression in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--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 LHRH agonist; No concurrent hormonal therapy, including corticosteroids for cancer treatment
• Radiotherapy: No concurrent radiotherapy
• Surgery: See Disease Characteristics
• Other: No other concurrent investigational agents

--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 history of 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 medical or psychiatric conditions that would preclude study

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Aminah Jatoi,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000067842; NCCTG-N9951
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005828
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08