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A Multicenter,Randomized,Placebo-Controlled,Double-Blind,Phase3 Trial of Single Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in Early Post Operative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

A Multicenter,Randomized,Placebo-Controlled,Double-Blind,Phase3 Trial of Single Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in Early Post Operative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer


This is a multicenter, randomized, placebo-controlled, double-blind, study. Following
TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® or
matching placebo instilled within 6 hours of surgery. Patients will be seen for a
postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report
will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade [WHO/ISUP
classification]), then the patient will receive no further treatment and will be observed
cystoscopically every three months through year two for tumor recurrence and progression.
If the histology of the patient's tumor is other than Ta, G1-G2 (low grade [WHO/ISUP
classification]), then the patient will receive further treatment in accordance with current
treatment guidelines, following which the patient will be followed up cystoscopically every
three months through year two for tumor recurrence and progression.


Inclusion Criteria:

(All questions must be answered YES)

- Has the patient given written informed consent?

- Is the patient at least 18 years old?

- Does the patient have transitional cell carcinoma of the bladder with clinically
apparent stage Ta, grade G1-G2?

- If the patient is a female of childbearing potential, is she using an
acceptable/effective method of contraception?

- If the patient is a female of childbearing potential, has she had a negative serum
pregnancy test within the past 14 days?

- Is the patient willing and able to abide by the protocol?

Exclusion Criteria: (All questions must be answered NO)

- Does the patient have more than 4 bladder tumors?

- Does any single bladder tumor exceed 3.5 cm in diameter?

- Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor
<0.5 cm?

- Has the patient ever received EOquin(r)?

- Does the patient have, or has the patient ever had, any bladder tumor known to be
other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?

- Does the patient have, or has the patient ever had any bladder tumor with histology
other than transitional cell carcinoma?

- Does the patient have, or has the patient ever had, CIS?

- Does the patient have an active urinary tract infection?

- Does the patient have a bleeding disorder or a screening platelet count < 100 x
10^9/L?

- Does the patient have any unstable medical condition that would make it unsafe for
him/her to undergo TUR-BT under general or spinal anesthesia?

- Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute
neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?

- Does the patient have a known immunodeficiency disorder?

- Has the patient received any investigational treatment within the past 30 days?

- Is the patient breast feeding?

- Does the patient have a history of interstitial cystitis?

- Does the patient have a history of allergy to red color food dye?

- Has the patient had transitional cell carcinoma of the bladder within the past 4
months?

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Recurrence Rate at 2 years

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mark Soloway, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami

Authority:

United States: Food and Drug Administration

Study ID:

SPI-611

NCT ID:

NCT00461591

Start Date:

April 2007

Completion Date:

April 2012

Related Keywords:

  • Bladder Cancer
  • Noninvasive Bladder Cancer
  • Urinary Bladder Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Urology San Antonio ResearchSan Antonio, Texas  78229
Urology Clinics of North TexasDallas, Texas  75231
Seattle Urological AssociatesSeattle, Washington  98104-1360
North Idaho UrologyCouer D'Alene, Idaho  83814
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Advanced Research InstituteNew Port Richey, Florida  34652
Lakeland Regional Cancer CenterLakeland, Florida  33805
University of ChicagoChicago, Illinois  60637
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Urology Associates of Central CAFresno, California  93720
Florida Foundation for Healthcare ResearchOcala, Florida  34474
AccuMed Research AssociatesGarden City, New York  11530
Michigan Institute Of Urology, PcSt. Clair Shores, Michigan  48081
Lakeside Urology, PCSt. Joseph, Michigan  49085
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
South Orange County Medical Research CenterLaguna Hills, California  92653
VA Medical CenterLoma Linda, California  92354-3866
Northeast Indiana Research, LLCFort Wayne, Indiana  46825-1675
University of MiamiMiami, Florida  33136
Hudson Valley UrologyPoughkeepsie, New York  12601
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Urology of Virginia, PCNorfolk, Virginia  23507
Metropolitan UrologyJeffersonville, Indiana  47130
Urology Group of New MexicoAlbuquerque, New Mexico  87109
Regional Urology, LLCShreveport, Louisiana  71106
Hudson Valley Urology, PCPoughkeepsie, New York  12601
Urology ConsultantsSafety Harbor, Florida  34695
Columbus Urology Research, LLCColumbus, Ohio  43214
Anne Arundel UrologyAnnapolis, Maryland  21401
BCG OncologyPhoenix, Arizona  85032
Florida Urology SpecialistsSarasota, Florida  34237
University Urology AssociatesNew York, New York  10016
Kaiser Permanente Los Angeles Medical CenterLos Angeles, California  90027
Oregon Urology InstituteSpringfield, Oregon  97477
Triangle Urology GroupPittsburgh, Pennsylvania  15212
Sun Health Research InstituteSun City, Arizona  85032
Urology Associates Medical GroupBurbank, California  91505
Cancer Research Dept/St. Joseph HospitalOrange, California  92868
San Bernardino Urologic AssociationSan Bernardino, California  92404
The Urology Center of ColoradoDenver, Colorado  80211
Urologic Surgeons of WashingtonWashington, District of Columbia  20006
Southeastern Research Group, Inc.Tallahassee, Florida  32308
Gainesville Urology, PCGainesville, Georgia  30501
Urological Professional AssociationMacon, Georgia  31217
Idaho Urologic Institute, P.A.Meridian, Idaho  83642
Urology Associates, SCMattoon, Illinois  61938
Speciality Care ResearchPeoria, Illinois  61614
Kansas City Urology Care, P.A.Overland Park, Kansas  66211
Myron Murdock, MD, LLCGreenbelt, Maryland  20770
MMPC UrologyGrand Rapids, Michigan  49546
Five Valleys UrologyMissoula, Montana  59802
Coastal Urological Associates, PABrick, New Jersey  08724
AdvanceMed ResearchLawrenceville, New Jersey  08648
Delaware Valley Urology, LLC-MarltonMarlton, New Jersey  08053
Deleware Valley Urology, LLC-Washington TownshipSewell, New Jersey  08080
Delaware Valley Urology, LLC - VoorheesVoorhees, New Jersey  08043
Delaware Valley Urology, LLC-WestamptonWestampton, New Jersey  08060
The Urological Institute of NE NYAlbany, New York  12208
Capital Region Urological SurgeonsAlbany, New York  12208
Adult and Pediatric UrologyCarmel, New York  10512
Urological Surgeons of Long Island, P.C.Garden City, New York  11530
CNY Urology, PCOneida, New York  13421
Urology Associates of Rochester, LLCRochester, New York  14618
Center for Urologic Research of WNY, LLCWilliamsville, New York  14221
TriState Urologic Services PSC, Inc.Cincinnati, Ohio  45212
Urologic Consultants of South Eastern PennsylvaniaBala Cynwyd, Pennsylvania  19026
Susquehenna UrologyWilliamsport, Pennsylvania  17701
The Conrad Pearson ClinicGermantown, Tennessee  38138
Corpus Christi Urology Group LLCCorpus Christi, Texas  78404
Mary Washington Hospital and Urology Associates of FredericksburgFredericksburg, Virginia  22401
Integrity Medical Research, LLCMountlake Terrace, Washington  98043