Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
- Registration Number
- NCT00461591
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 802
(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?
(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 Apaziquone?
- 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, carcinoma in situ (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 TURBT 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?
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT Placebo TURBT TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT Apaziquone TURBT TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT Apaziquone Apaziquone TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
- Primary Outcome Measures
Name Time Method Recurrence Rate at 2 Years 2 years The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
- Secondary Outcome Measures
Name Time Method Time to Progression 2 years The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Time to Recurrence 2 years The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Progression Rate at 2 Years 2 years The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.
Number of Recurrences Per Patient 2 years The number of histologically confirmed recurrences during the course of the study.
Disease Free Interval 2 years The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Disease Free Survival 2 years The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Overall Survival 2 years The number of months from randomization to death from any cause.
Trial Locations
- Locations (72)
Urology of Virginia, PC
🇺🇸Virginia Beach, Virginia, United States
Delaware Valley Urology, LLC - Voorhees
🇺🇸Voorhees, New Jersey, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Seattle Urological Associates
🇺🇸Seattle, Washington, United States
MMPC Urology
🇺🇸Grand Rapids, Michigan, United States
Lakeside Urology, PC
🇺🇸Saint Joseph, Michigan, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Michigan Institute of Urology, PC
🇺🇸Troy, Michigan, United States
Deleware Valley Urology, LLC-Washington Township
🇺🇸Sewell, New Jersey, United States
Delaware Valley Urology, LLC-Westampton
🇺🇸Westampton, New Jersey, United States
CNY Urology, PC
🇺🇸Oneida, New York, United States
Corpus Christi Urology Group LLC
🇺🇸Corpus Christi, Texas, United States
University Urology Associates
🇺🇸New York, New York, United States
Susquehenna Urology
🇺🇸Williamsport, Pennsylvania, United States
The Conrad Pearson Clinic
🇺🇸Germantown, Tennessee, United States
BCG Oncology
🇺🇸Phoenix, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
TriState Urologic Services PSC, Inc.
🇺🇸Cincinnati, Ohio, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Five Valleys Urology
🇺🇸Missoula, Montana, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Hudson Valley Urology, PC
🇺🇸Kingston, New York, United States
Capital Region Urological Surgeons
🇺🇸Albany, New York, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Urology Associates of Central CA
🇺🇸Fresno, California, United States
Urology Associates Medical Group
🇺🇸Burbank, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods, California, United States
Cancer Research Dept/St. Joseph Hospital
🇺🇸Orange, California, United States
San Bernardino Urologic Association
🇺🇸San Bernardino, California, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Urologic Surgeons of Washington
🇺🇸Washington, District of Columbia, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Florida Urology Specialists
🇺🇸Sarasota, Florida, United States
Gainesville Urology, PC
🇺🇸Gainesville, Georgia, United States
Southeastern Research Group, Inc.
🇺🇸Tallahassee, Florida, United States
Urological Professional Association
🇺🇸Macon, Georgia, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Urology Associates, SC
🇺🇸Mattoon, Illinois, United States
Northeast Indiana Research, LLC
🇺🇸Fort Wayne, Indiana, United States
Anne Arundel Urology
🇺🇸Annapolis, Maryland, United States
Myron Murdock, MD, LLC
🇺🇸Greenbelt, Maryland, United States
Coastal Urological Associates, PA
🇺🇸Brick, New Jersey, United States
Columbus Urology Research, LLC
🇺🇸Columbus, Ohio, United States
Urological Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
VA Medical Center
🇺🇸San Francisco, California, United States
Florida Foundation for Healthcare Research
🇺🇸Ocala, Florida, United States
Kansas City Urology Care, P.A.
🇺🇸Overland Park, Kansas, United States
Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
Urology Consultants
🇺🇸Longwood, Florida, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Metropolitan Urology
🇺🇸Jeffersonville, Indiana, United States
Connecticut Clinical Research Center
🇺🇸Middlebury, Connecticut, United States
Speciality Care Research
🇺🇸Peoria, Illinois, United States
The Urological Institute of NE NY
🇺🇸Albany, New York, United States
Mary Washington Hospital and Urology Associates of Fredericksburg
🇺🇸Fredericksburg, Virginia, United States
Idaho Urologic Institute, P.A.
🇺🇸Meridian, Idaho, United States
Integrity Medical Research, LLC
🇺🇸Mountlake Terrace, Washington, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Accumed Research Associates
🇺🇸Garden City, New York, United States
Triangle Urology Group
🇺🇸Pittsburgh, Pennsylvania, United States
Urology Associates of Rochester, LLC
🇺🇸Rochester, New York, United States
AdvanceMed Research
🇺🇸Lawrenceville, New Jersey, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
Center for Urologic Research of WNY, LLC
🇺🇸Williamsville, New York, United States
Adult and Pediatric Urology
🇺🇸Carmel, New York, United States
Urological Surgeons of Long Island, P.C.
🇺🇸Garden City, New York, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Urologic Consultants of South Eastern Pennsylvania
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Delaware Valley Urology, LLC-Marlton
🇺🇸Marlton, New Jersey, United States