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
18 Years
N/A
Both
Bladder Cancer
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 Center | Philadelphia, Pennsylvania 19111 |
| Urology San Antonio Research | San Antonio, Texas 78229 |
| Urology Clinics of North Texas | Dallas, Texas 75231 |
| Seattle Urological Associates | Seattle, Washington 98104-1360 |
| North Idaho Urology | Couer D'Alene, Idaho 83814 |
| Connecticut Clinical Research Center | Waterbury, Connecticut 06708-2652 |
| Advanced Research Institute | New Port Richey, Florida 34652 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| University of Chicago | Chicago, Illinois 60637 |
| Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
| Urology Associates of Central CA | Fresno, California 93720 |
| Florida Foundation for Healthcare Research | Ocala, Florida 34474 |
| AccuMed Research Associates | Garden City, New York 11530 |
| Michigan Institute Of Urology, Pc | St. Clair Shores, Michigan 48081 |
| Lakeside Urology, PC | St. Joseph, Michigan 49085 |
| Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
| South Orange County Medical Research Center | Laguna Hills, California 92653 |
| VA Medical Center | Loma Linda, California 92354-3866 |
| Northeast Indiana Research, LLC | Fort Wayne, Indiana 46825-1675 |
| University of Miami | Miami, Florida 33136 |
| Hudson Valley Urology | Poughkeepsie, New York 12601 |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
| Urology of Virginia, PC | Norfolk, Virginia 23507 |
| Metropolitan Urology | Jeffersonville, Indiana 47130 |
| Urology Group of New Mexico | Albuquerque, New Mexico 87109 |
| Regional Urology, LLC | Shreveport, Louisiana 71106 |
| Hudson Valley Urology, PC | Poughkeepsie, New York 12601 |
| Urology Consultants | Safety Harbor, Florida 34695 |
| Columbus Urology Research, LLC | Columbus, Ohio 43214 |
| Anne Arundel Urology | Annapolis, Maryland 21401 |
| BCG Oncology | Phoenix, Arizona 85032 |
| Florida Urology Specialists | Sarasota, Florida 34237 |
| University Urology Associates | New York, New York 10016 |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles, California 90027 |
| Oregon Urology Institute | Springfield, Oregon 97477 |
| Triangle Urology Group | Pittsburgh, Pennsylvania 15212 |
| Sun Health Research Institute | Sun City, Arizona 85032 |
| Urology Associates Medical Group | Burbank, California 91505 |
| Cancer Research Dept/St. Joseph Hospital | Orange, California 92868 |
| San Bernardino Urologic Association | San Bernardino, California 92404 |
| The Urology Center of Colorado | Denver, Colorado 80211 |
| Urologic Surgeons of Washington | Washington, District of Columbia 20006 |
| Southeastern Research Group, Inc. | Tallahassee, Florida 32308 |
| Gainesville Urology, PC | Gainesville, Georgia 30501 |
| Urological Professional Association | Macon, Georgia 31217 |
| Idaho Urologic Institute, P.A. | Meridian, Idaho 83642 |
| Urology Associates, SC | Mattoon, Illinois 61938 |
| Speciality Care Research | Peoria, Illinois 61614 |
| Kansas City Urology Care, P.A. | Overland Park, Kansas 66211 |
| Myron Murdock, MD, LLC | Greenbelt, Maryland 20770 |
| MMPC Urology | Grand Rapids, Michigan 49546 |
| Five Valleys Urology | Missoula, Montana 59802 |
| Coastal Urological Associates, PA | Brick, New Jersey 08724 |
| AdvanceMed Research | Lawrenceville, New Jersey 08648 |
| Delaware Valley Urology, LLC-Marlton | Marlton, New Jersey 08053 |
| Deleware Valley Urology, LLC-Washington Township | Sewell, New Jersey 08080 |
| Delaware Valley Urology, LLC - Voorhees | Voorhees, New Jersey 08043 |
| Delaware Valley Urology, LLC-Westampton | Westampton, New Jersey 08060 |
| The Urological Institute of NE NY | Albany, New York 12208 |
| Capital Region Urological Surgeons | Albany, New York 12208 |
| Adult and Pediatric Urology | Carmel, New York 10512 |
| Urological Surgeons of Long Island, P.C. | Garden City, New York 11530 |
| CNY Urology, PC | Oneida, New York 13421 |
| Urology Associates of Rochester, LLC | Rochester, New York 14618 |
| Center for Urologic Research of WNY, LLC | Williamsville, New York 14221 |
| TriState Urologic Services PSC, Inc. | Cincinnati, Ohio 45212 |
| Urologic Consultants of South Eastern Pennsylvania | Bala Cynwyd, Pennsylvania 19026 |
| Susquehenna Urology | Williamsport, Pennsylvania 17701 |
| The Conrad Pearson Clinic | Germantown, Tennessee 38138 |
| Corpus Christi Urology Group LLC | Corpus Christi, Texas 78404 |
| Mary Washington Hospital and Urology Associates of Fredericksburg | Fredericksburg, Virginia 22401 |
| Integrity Medical Research, LLC | Mountlake Terrace, Washington 98043 |
