Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
NCT ID: NCT00461591
Last Updated: 2021-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
802 participants
INTERVENTIONAL
2007-04-30
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apaziquone
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Apaziquone
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
TURBT
TransUrethral Resection of the Bladder Tumor
Placebo
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Placebo
A single intravesical dose of placebo instilled into the bladder post-TURBT
TURBT
TransUrethral Resection of the Bladder Tumor
Interventions
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Apaziquone
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo
A single intravesical dose of placebo instilled into the bladder post-TURBT
TURBT
TransUrethral Resection of the Bladder Tumor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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?
18 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Shanta Chawla, MD
Role: STUDY_DIRECTOR
Spectrum Pharmaceuticals, Inc
Locations
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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 D.C., 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 Township, New Jersey, United States
Delaware Valley Urology, LLC-Westampton
Woodlane, 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
Countries
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Other Identifiers
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SPI-611
Identifier Type: -
Identifier Source: org_study_id
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