RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving genistein before surgery may shrink the tumor so it can be removed. It is not yet known whether genistein is more effective than placebo in treating bladder cancer.

PURPOSE: This randomized phase II trial is studying genistein to see how well it works compared to placebo in treating patients who are undergoing surgery for bladder cancer.

Condition	Intervention	Phase
stage 0 bladder cancer recurrent bladder cancer stage I bladder cancer stage II bladder cancer stage III bladder cancer stage IV bladder cancer	Drug: genistein  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: conventional surgery  Procedure: enzyme inhibitor therapy  Procedure: herbal medicine / botanical therapy  Procedure: neoadjuvant therapy  Procedure: nutritional supplementation  Procedure: phytoestrogen therapy  Procedure: protein tyrosine kinase inhibitor therapy  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Compare the effect of genistein vs placebo on epidermal growth factor receptor phosphorylation, as measured by immunohistochemistry, in patients undergoing surgical resection for bladder cancer.

Secondary

• Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to invasiveness of disease (non-invasive [stage Ta, Tis, or T1] vs invasive [stage T2, T3, or T4]). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive oral genistein twice daily for approximately 14-30 days.
• Arm II: Patients receive oral genistein as in arm I but at a higher dose.
• Arm III: Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of primary bladder cancer by cystoscopy within the past 60 days*
• Initial diagnosis or recurrent disease
• Any clinical stage NOTE: *Diagnostic cystoscopy must be performed ≥ 90 days after treatment with BCG or other agents for bladder cancer (for patients with recurrent disease)
• Candidate for subsequent cystoscopic excision, transurethral resection of the bladder tumor, or complete or partial cystectomy
• No evidence of distant metastasis

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 1.4 mg/dL
• AST ≤ 3 times normal
• Amylase ≤ 3 times normal

Renal

• Creatinine ≤ 2.0 mg/dL
• Calcium ≤ 10.2 mg/dL

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No uncontrolled cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Sodium 125-155 mmol/L
• Potassium 3.2-6 mmol/L
• Chloride 85-114 mmol/L
• Carbon dioxide ≥ 11 mEq/dL
• Thyroid-stimulating hormone and total T4 1.5 times high and low range of normal
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to genistein or soy isoflavones
• No other allergy to soy-based products
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic irradiation

Surgery

• See Disease Characteristics

Other

• No other concurrent investigational agents
• No other concurrent soy supplements
• No concurrent thyroid medications
• No concurrent non-steroidal anti-inflammatory drugs, including aspirin
• Concurrent cardioprotective doses of aspirin (≤ 81 mg/day) allowed
• No other concurrent systemic anticancer therapy
• No other concurrent treatment for bladder cancer between the pre-enrollment cystoscopy and subsequent surgery

Please refer to this study by ClinicalTrials.gov identifier  NCT00118040

Alabama
      Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      Orange County Urology Associates, Incorporated, Laguna Hills,  California,  92653,  United States; Recruiting
Georgia
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Texas
      Urology San Antonio, P.A. - Fredericksburg, San Antonio,  Texas,  78229,  United States; Recruiting
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States; Recruiting

Study chairs or principal investigators

Edward M. Messing, MD, FACS,  Study Chair,  James P. Wilmot Cancer Center   
Howard H. Bailey, MD,  Principal Investigator,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000433520; WCCC-CO-04307; WCCC-UWI03-1-01; WCCC-H-2005-0026; NCT00118040
Record last reviewed:  June 2005
Last Updated:  July 21, 2005
Record first received:  July 8, 2005
ClinicalTrials.gov Identifier:  NCT00118040
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26