Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer

• Status: Completed
• Trial end date: 2017-06-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Epigallocatechin gallate

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