Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
- Registration Number
- NCT00598806
- 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
- 812
All of the following questions must be answered "Yes" in order for the patient to participate in the study.
- 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 tumor 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 of the following questions must be answered "No" in order for the patient to participate in the study.
- Does the patient have more than 5 bladder tumors?
- Does any single bladder tumor exceed 3.5 cm in diameter?
- Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer?
- 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 tumor 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 109/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 screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L?
- 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 Apaziquone TURBT TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT 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 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 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.
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.
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
Number of Recurrences Per Patient 2 years The number of histologically confirmed recurrences during the course of the study.
Overall Survival 2 years The number of months from randomization to death from any cause.
Time to Recurrence 2 years The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Trial Locations
- Locations (76)
PharmaTrials, Inc.
🇺🇸Hillsborough, New Jersey, United States
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
🇵🇱Pabianice, Poland
Advanced Urology Medical Center Clinical Trials
🇺🇸Anaheim, California, United States
Urology Associates, PC
🇺🇸Manhasset, New York, United States
Alliance Urology Specialists
🇺🇸Greensboro, North Carolina, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Saint Joseph Health Center
🇨🇦Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
The Male Health Centre
🇨🇦Toronto, Ontario, Canada
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Prostate Cancer Institute
🇨🇦Calgary, Alberta, Canada
Andreou Research
🇨🇦Surrey, British Columbia, Canada
Medical University of South Carolina, Dept. of Urology
🇺🇸Charleston, South Carolina, United States
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
🇵🇱Inowrocław, Poland
The Urology Center
🇺🇸Slidell, Louisiana, United States
Szpital Miejski im. Prof. E. Michałowskiego
🇵🇱Katowice, Poland
UroLaval
🇨🇦Laval, Quebec, Canada
PharmaTrials, Inc. - Male & Female Urology
🇺🇸Hillsborough, New Jersey, United States
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
🇵🇱Gdańsk, Poland
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
🇵🇱Pruszków, Poland
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
G. Steinhoff Clinical Research
🇨🇦Victoria, British Columbia, Canada
Ultra-Med, Inc.
🇨🇦Pointe Clare, Quebec, Canada
McGill Urology Associates
🇨🇦Montreal, Quebec, Canada
Uniwersytecki Szpital Kliniczny
🇵🇱Białystok, Poland
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
🇵🇱Kraków, Poland
Wojewódzki Szpital Specjalistyczny W Siedlcach
🇵🇱Siedlce, Poland
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
🇵🇱Warszawa, Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
🇵🇱Warszawa, Poland
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
🇵🇱Lublin, Poland
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
🇵🇱Poznań, Poland
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
🇵🇱Słupsk, Poland
Centrum Onkologii im. Marii Skodowskiej-Curie
🇵🇱Warszawa, Poland
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
🇵🇱Wrocław, Poland
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
🇵🇱Łódź, Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
🇵🇱Wrocław, Poland
North Fulton Urology
🇺🇸Roswell, Georgia, United States
Hal J. Bashein, D.O.
🇺🇸West Palm Beach, Florida, United States
Urology Enterprises
🇺🇸Marietta, Georgia, United States
Hines VA Hospital
🇺🇸Hines, Illinois, United States
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
Medical & Clinical Research Associates, LLC
🇺🇸Bay Shore, New York, United States
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
🇺🇸New Hyde Park, New York, United States
Urology Associates of South Texas
🇺🇸McAllen, Texas, United States
Center for Urologic Care
🇺🇸Bryn Mawr, Pennsylvania, United States
Adult and Pediatric Urologists
🇺🇸Alexandria, Virginia, United States
Can-Med Clinical Research, Inc
🇨🇦Victoria, British Columbia, Canada
Lintor Medical, Inc.
🇨🇦North Vancouver, British Columbia, 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
Urology Associates, Urologic Medical Research
🇨🇦Kitchener, Ontario, Canada
Kingston General Hospital / Queen's University
🇨🇦Kingston, Ontario, Canada
Mor Urology, Inc.
🇨🇦Newmarket, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Dr. Bernard Goldfarb
🇨🇦North Bay, Ontario, Canada
The Fe/Male Health Centre
🇨🇦Oakville, Ontario, Canada
Orillia Urology Associates
🇨🇦Orillia, Ontario, Canada
Stanley Flax Medical Professional Corporation
🇨🇦North York, Ontario, Canada
Urotec
🇨🇦Oshawa, Ontario, Canada
ADA Medical Ltd.
🇨🇦Peterborough, Ontario, Canada
Urology & Male Infertility
🇨🇦Scarborough, Ontario, Canada
AGT Research
🇨🇦Scarborough, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Centre hospitalier universitaire de Quebec
🇨🇦Quebec, Canada
Szpital Wojewódzki w Bielsku-Białej
🇵🇱Bielsko-Biała, Poland
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
🇵🇱Kielce, Poland
Szpital Specjalistyczny w Kościerzynie
🇵🇱Kościerzyna, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
🇵🇱Rybnik, Poland
Pomorska Akademia Medyczna
🇵🇱Szczecin, Poland
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
🇵🇱Warszawa, Poland
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada