Status:
COMPLETED
Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Stage I Bladder Cancer
Stage II Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES I. To compare the levels of epigallocatechin-3-gallate (EGCG) in nonmalignant bladder tissue from patients with bladder cancer treated with oral polyphenon E 800 mg EGCG or polyphen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00666562
Start Date
July 2 2008
End Date
June 9 2017
Last Update
November 17 2017
Active Locations (6)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
3
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States, 55417
4
University of Rochester
Rochester, New York, United States, 14642