Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
NCT ID: NCT00598806
Last Updated: 2017-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
812 participants
INTERVENTIONAL
2007-08-31
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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Keywords
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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
1. Has the patient given written informed consent?
2. Is the patient at least 18 years old?
3. Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2?
4. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
5. If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
6. Is the patient willing and able to abide by the protocol?
Exclusion Criteria
1. Does the patient have more than 5 bladder tumors?
2. Does any single bladder tumor exceed 3.5 cm in diameter?
3. Does the patient have a single, primary bladder tumor \<0.5 cm and has no previous diagnosis of bladder cancer?
4. Has the patient ever received EOquin(r)?
5. Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade \[WHO/ISUP classification\])?
6. Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
7. Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
8. Does the patient have an active urinary tract infection?
9. Does the patient have a bleeding disorder or a screening platelet count \< 100 x 109/L?
10. Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
11. Does the patient have screening hemoglobin \< 10 mg/dL, a screening absolute neutrophil count \< 1.5 x 109/L?
12. Does the patient have a known immunodeficiency disorder?
13. Has the patient received any investigational treatment within the past 30 days?
14. Is the patient breast feeding?
15. Does the patient have a history of interstitial cystitis?
16. Does the patient have a history of allergy to red color food dye?
17. 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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Advanced Urology Medical Center Clinical Trials
Anaheim, California, United States
Hal J. Bashein, D.O.
West Palm Beach, Florida, United States
Urology Enterprises
Marietta, Georgia, United States
North Fulton Urology
Roswell, Georgia, United States
Hines VA Hospital
Hines, Illinois, United States
The Urology Center
Slidell, Louisiana, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
PharmaTrials, Inc. - Male & Female Urology
Hillsborough, New Jersey, United States
PharmaTrials, Inc.
Hillsborough, New Jersey, United States
Medical & Clinical Research Associates, LLC
Bay Shore, New York, United States
Urology Associates, PC
Manhasset, New York, United States
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
New Hyde Park, New York, United States
Alliance Urology Specialists
Greensboro, North Carolina, United States
Piedmont Medical Research
Winston-Salem, North Carolina, United States
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States
Medical University of South Carolina, Dept. of Urology
Charleston, South Carolina, United States
Urology Associates of South Texas
McAllen, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Adult and Pediatric Urologists
Alexandria, Virginia, United States
Prostate Cancer Institute
Calgary, Alberta, Canada
Lintor Medical, Inc.
North Vancouver, British Columbia, Canada
Andreou Research
Surrey, British Columbia, Canada
Can-Med Clinical Research, Inc
Victoria, British Columbia, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
The Male/Female Health and Research Center - Royal Court Medical Centre
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada
Urology Resource Centre
Burlington, Ontario, Canada
Kingston General Hospital / Queen's University
Kingston, Ontario, Canada
Urology Associates, Urologic Medical Research
Kitchener, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Mor Urology, Inc.
Newmarket, Ontario, Canada
Dr. Bernard Goldfarb
North Bay, Ontario, Canada
Stanley Flax Medical Professional Corporation
North York, Ontario, Canada
The Fe/Male Health Centre
Oakville, Ontario, Canada
Orillia Urology Associates
Orillia, Ontario, Canada
Urotec
Oshawa, Ontario, Canada
ADA Medical Ltd.
Peterborough, Ontario, Canada
AGT Research
Scarborough Village, Ontario, Canada
Urology & Male Infertility
Scarborough Village, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada
The Male Health Centre
Toronto, Ontario, Canada
Saint Joseph Health Center
Toronto, Ontario, Canada
UroLaval
Laval, Quebec, Canada
McGill Urology Associates
Montreal, Quebec, Canada
Ultra-Med, Inc.
Pointe Clare, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Centre hospitalier universitaire de Quebec
Québec, , Canada
Uniwersytecki Szpital Kliniczny
Bialystok, , Poland
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biala, , Poland
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
Gdansk, , Poland
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
Inowrocław, , Poland
Szpital Miejski im. Prof. E. Michałowskiego
Katowice, , Poland
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce, , Poland
Szpital Specjalistyczny w Kościerzynie
Kościerzyna, , Poland
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
Krakow, , Poland
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
Pabianice, , Poland
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
Poznan, , Poland
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
Pruszków, , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
Rybnik, , Poland
Wojewódzki Szpital Specjalistyczny W Siedlcach
Siedlce, , Poland
Pomorska Akademia Medyczna
Szczecin, , Poland
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, , Poland
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warsaw, , Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warsaw, , Poland
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
Warsaw, , Poland
Centrum Onkologii im. Marii Skodowskiej-Curie
Warsaw, , Poland
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
Warsaw, , Poland
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
Wroclaw, , Poland
Countries
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Other Identifiers
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SPI-612
Identifier Type: -
Identifier Source: org_study_id