Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer

NCT00666562 | Completed Phase 2 Results

• 7 other identifiers: NCI-2009-00906CO06810CDR0000594276H-2007-0250UWI06-8-01N01CN35153P30CA014520
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Stage I Bladder Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)

  Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.

  up to 28 days

Secondary Outcomes (12)

• Levels of EGCG in Malignant Bladder Tissue

  up to 28 days

• Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry

  up to 28 days

• Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA

  Baseline and up to day 28

• Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples

  up to 28 days

• Absolute Change for Baseline From EGCG in Serum Samples

  Baseline and up to 28 days

Study Arms (3)

Arm I (placebo)

PLACEBO COMPARATOR

Patients receive six oral placebo capsules once daily for 14-28 days.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Placebo

Arm II (polyphenon E, placebo)

EXPERIMENTAL

Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.

Dietary Supplement: Defined Green Tea Catechin Extract; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Placebo

Arm III (polyphenon E, trans-urethral resection or cystectomy)

EXPERIMENTAL

Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

Dietary Supplement: Defined Green Tea Catechin Extract; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Therapeutic Conventional Surgery

Interventions

Defined Green Tea Catechin Extract DIETARY_SUPPLEMENT

Given orally

Also known as: Polyphenon E, Polyphenon E TM

Arm II (polyphenon E, placebo); Arm III (polyphenon E, trans-urethral resection or cystectomy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (placebo); Arm II (polyphenon E, placebo); Arm III (polyphenon E, trans-urethral resection or cystectomy)

Pharmacological Study OTHER

Correlative studies

Arm I (placebo); Arm II (polyphenon E, placebo); Arm III (polyphenon E, trans-urethral resection or cystectomy)

Placebo DRUG

Given orally

Also known as: placebo therapy, PLCB, sham therapy

Arm I (placebo); Arm II (polyphenon E, placebo)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Arm III (polyphenon E, trans-urethral resection or cystectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (6)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Minneapolis Veterans Medical Center

Minneapolis, Minnesota, 55417, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Urology San Antonio Research PA

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Howard H. Bailey
• Organization: University of Wisconsin

hhbailey@wisc.edu

608-263-8624

Study Officials

• Tracy Downs

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: July 2, 2008
• Primary Completion: April 26, 2012
• Study Completion: June 9, 2017
• Last Updated: November 17, 2017
• Results First Posted: March 28, 2016

Record last verified: 2017-10

Locations

US (6)