Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
Condition: Stage I Bladder Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Defined Green Tea Catechin Extract; Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Therapeutic Conventional Surgery
Intervention description: Given orally; Correlative studies; Correlative studies; Given orally; Undergo surgery
Intervention MeSH terms: Epigallocatechin gallate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Green tea extract contains ingredients that may slow the growth of certain cancers. It is not
      yet known whether green tea extract is more effective than a placebo when given before
      surgery in treating patients with bladder. This randomized phase II trial is studying green
      tea extract to see how well it works compared to a placebo when given before surgery in
      treating patients with nonmetastatic bladder cancer.
    

Eligibility criteria:

        Criteria:

          -  Diagnosis of bladder cancer

          -  Bladder tumor discovered on cystoscopy within the past 60 days

          -  Invasive or non-invasive tumor

          -  Primary tumor may represent either an initial diagnosis or recurrent disease of any
             clinical stage

          -  No metastatic disease

          -  Must be an eligible candidate for a partial cystectomy, radical cystectomy, or
             trans-urethral resection of bladder tumor (TURBT)

          -  Has not undergone any treatment for superficial or invasive bladder cancer since the
             diagnostic cystoscopy

          -  TURBT or radical cystectomy is the planned curative surgical treatment

          -  ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

          -  More than 30 days since any prior intravesical therapy or adjuvant chemotherapy

          -  More than 30 days since prior bladder surgery

          -  Biopsies are not considered surgeries

          -  No prior pelvic radiotherapy

          -  No concurrent systemic chemotherapy for any other cancer, except nonmelanoma skin
             cancer

          -  No concurrent NSAIDs (e.g., ibuprofen, naproxen, or cyclooxygenase-2 inhibitors)
             except =< 81 mg aspirin per day

          -  Concurrent acetaminophen (Tylenol) or prescription opioids combined with acetaminophen
             (i.e., Percocet, Darvocet, Vicodin, Tylenol #3) allowed for pain

          -  No other concurrent investigational agents

          -  White Blood Cell (WBC) >= 3,000/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Hemoglobin >= 10 g/dL

          -  Alkaline phosphatase =< upper limit of normal (ULN)

          -  Bilirubin =< ULN

          -  Asparate Aminotransferase (AST) and Alanine Transaminase (ALT) =< ULN

          -  Sodium 135-144 mmol/L (inclusive)

          -  Potassium 3.2-4.8 mmol/L (inclusive)

          -  Chloride 85-114 mmol/L (inclusive)

          -  Bicarbonate >11 mEQ/dL

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to avoid green tea beverages and green tea-containing products during study
             participation

          -  No evidence of other cancers, except nonmelanoma skin cancer

          -  No history of allergic reactions attributed to tea or to any of the compounds of
             similar chemical or biologic composition to Polyphenon E or any of the inactive
             ingredients in Polyphenon E capsules

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable
             angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would
             limit study compliance

          -  More than 24 hours since prior and no concurrent consumption of any other green tea
             supplements or more than 2 cups (16 oz) of green tea either through dietary sources or
             through nutritional supplementation

          -  Topical cosmetics (i.e., lotions, shampoos, makeup) that contain green tea are allowed

          -  Creatinine normal

          -  Not pregnant or nursing