Spots Global Cancer Trial Database for Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
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Trial Identification
Brief Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-611)
Study ID: NCT00461591
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
Detailed Description: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder. A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3). * If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). * If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). All patients were to be followed for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States
BCG Oncology, Phoenix, Arizona, United States
Sun Health Research Institute, Sun City, Arizona, United States
Urology Associates Medical Group, Burbank, California, United States
Urology Associates of Central CA, Fresno, California, United States
South Orange County Medical Research Center, Laguna Woods, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Cancer Research Dept/St. Joseph Hospital, Orange, California, United States
San Bernardino Urologic Association, San Bernardino, California, United States
VA Medical Center, San Francisco, California, United States
The Urology Center of Colorado, Denver, Colorado, United States
Connecticut Clinical Research Center, Middlebury, Connecticut, United States
Urologic Surgeons of Washington, Washington, District of Columbia, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Urology Consultants, Longwood, Florida, United States
University of Miami, Miami, Florida, United States
Advanced Research Institute, New Port Richey, Florida, United States
Advanced Research Institute, New Port Richey, Florida, United States
Florida Foundation for Healthcare Research, Ocala, Florida, United States
Florida Urology Specialists, Sarasota, Florida, United States
Southeastern Research Group, Inc., Tallahassee, Florida, United States
Gainesville Urology, PC, Gainesville, Georgia, United States
Urological Professional Association, Macon, Georgia, United States
North Idaho Urology, Coeur d'Alene, Idaho, United States
Idaho Urologic Institute, P.A., Meridian, Idaho, United States
University of Chicago, Chicago, Illinois, United States
Urology Associates, SC, Mattoon, Illinois, United States
Speciality Care Research, Peoria, Illinois, United States
Northeast Indiana Research, LLC, Fort Wayne, Indiana, United States
Metropolitan Urology, Jeffersonville, Indiana, United States
Kansas City Urology Care, P.A., Overland Park, Kansas, United States
Regional Urology, LLC, Shreveport, Louisiana, United States
Anne Arundel Urology, Annapolis, Maryland, United States
Myron Murdock, MD, LLC, Greenbelt, Maryland, United States
MMPC Urology, Grand Rapids, Michigan, United States
Lakeside Urology, PC, Saint Joseph, Michigan, United States
Michigan Institute of Urology, PC, Troy, Michigan, United States
Five Valleys Urology, Missoula, Montana, United States
Coastal Urological Associates, PA, Brick, New Jersey, United States
AdvanceMed Research, Lawrenceville, New Jersey, United States
Delaware Valley Urology, LLC-Marlton, Marlton, New Jersey, United States
Deleware Valley Urology, LLC-Washington Township, Sewell, New Jersey, United States
Delaware Valley Urology, LLC - Voorhees, Voorhees, New Jersey, United States
Delaware Valley Urology, LLC-Westampton, Westampton, New Jersey, United States
Urology Group of New Mexico, Albuquerque, New Mexico, United States
Capital Region Urological Surgeons, Albany, New York, United States
The Urological Institute of NE NY, Albany, New York, United States
Adult and Pediatric Urology, Carmel, New York, United States
Accumed Research Associates, Garden City, New York, United States
Urological Surgeons of Long Island, P.C., Garden City, New York, United States
Hudson Valley Urology, PC, Kingston, New York, United States
University Urology Associates, New York, New York, United States
CNY Urology, PC, Oneida, New York, United States
Hudson Valley Urology, Poughkeepsie, New York, United States
Urology Associates of Rochester, LLC, Rochester, New York, United States
Center for Urologic Research of WNY, LLC, Williamsville, New York, United States
TriState Urologic Services PSC, Inc., Cincinnati, Ohio, United States
Columbus Urology Research, LLC, Columbus, Ohio, United States
Oregon Urology Institute, Springfield, Oregon, United States
Urologic Consultants of South Eastern Pennsylvania, Bala-Cynwyd, Pennsylvania, United States
Urological Associates of Lancaster, Lancaster, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Triangle Urology Group, Pittsburgh, Pennsylvania, United States
Susquehenna Urology, Williamsport, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
The Conrad Pearson Clinic, Germantown, Tennessee, United States
Corpus Christi Urology Group LLC, Corpus Christi, Texas, United States
Urology Clinics of North Texas, Dallas, Texas, United States
Urology San Antonio Research, San Antonio, Texas, United States
Mary Washington Hospital and Urology Associates of Fredericksburg, Fredericksburg, Virginia, United States
Urology of Virginia, PC, Norfolk, Virginia, United States
Urology of Virginia, PC, Virginia Beach, Virginia, United States
Integrity Medical Research, LLC, Mountlake Terrace, Washington, United States
Seattle Urological Associates, Seattle, Washington, United States
Contact Details
Name: Shanta Chawla, MD
Affiliation: Spectrum Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
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