Clinical trial NCT00598806: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
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-612)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Noninvasive Bladder Cancer
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

All of the following questions must be answered "Yes" in order for the patient to participate in the study.

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:

All of the following questions must be answered "No" in order for the patient to participate in the study.

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?

Primary outcomes:
measure: Recurrence Rate at 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Time to Recurrence
timeFrame: 2 years
measure: Progression Rate at 2 Years
timeFrame: 2 years
measure: Time to Progression
timeFrame: 2 years
measure: Number of Recurrences Per Patient
timeFrame: 2 years
measure: Disease-Free Interval
timeFrame: 2 years
measure: Disease-Free Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Urology Medical Center Clinical Trials
state: California
city: West Palm Beach
country: United States
facility: Hal J. Bashein, D.O.
state: Florida
city: Marietta
country: United States
facility: Urology Enterprises
state: Georgia
city: Roswell
country: United States
facility: North Fulton Urology
state: Georgia
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
city: Slidell
country: United States
facility: The Urology Center
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Hillsborough
country: United States
facility: PharmaTrials, Inc. - Male & Female Urology
state: New Jersey
city: Hillsborough
country: United States
facility: PharmaTrials, Inc.
state: New Jersey
city: Bay Shore
country: United States
facility: Medical & Clinical Research Associates, LLC
state: New York
city: Manhasset
country: United States
facility: Urology Associates, PC
state: New York
city: New Hyde Park
country: United States
facility: North Shore - LIJ Health System - The Arthur Smith Institute for Urology
state: New York
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Bryn Mawr
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Dept. of Urology
state: South Carolina
city: McAllen
country: United States
facility: Urology Associates of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Alexandria
country: United States
facility: Adult and Pediatric Urologists
state: Virginia
city: Calgary
country: Canada
facility: Prostate Cancer Institute
state: Alberta
city: North Vancouver
country: Canada
facility: Lintor Medical, Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Andreou Research
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research, Inc
state: British Columbia
city: Victoria
country: Canada
facility: G. Steinhoff Clinical Research
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male/Female Health and Research Center - Royal Court Medical Centre
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Burlington
country: Canada
facility: Urology Resource Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital / Queen's University
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates, Urologic Medical Research
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Mor Urology, Inc.
state: Ontario
city: North Bay
country: Canada
facility: Dr. Bernard Goldfarb
state: Ontario
city: North York
country: Canada
facility: Stanley Flax Medical Professional Corporation
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centre
state: Ontario
city: Orillia
country: Canada
facility: Orillia Urology Associates
state: Ontario
city: Oshawa
country: Canada
facility: Urotec
state: Ontario
city: Peterborough
country: Canada
facility: ADA Medical Ltd.
state: Ontario
city: Scarborough
country: Canada
facility: AGT Research
state: Ontario
city: Scarborough
country: Canada
facility: Urology & Male Infertility
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Saint Joseph Health Center
state: Ontario
city: Laval
country: Canada
facility: UroLaval
state: Quebec
city: Montreal
country: Canada
facility: McGill Urology Associates
state: Quebec
city: Pointe Clare
country: Canada
facility: Ultra-Med, Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Centre hospitalier universitaire de Quebec
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Bielsko-Biała
country: Poland
facility: Szpital Wojewódzki w Bielsku-Białej
city: Gdańsk
country: Poland
facility: Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
city: Inowrocław
country: Poland
facility: Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
city: Katowice
country: Poland
facility: Szpital Miejski im. Prof. E. Michałowskiego
city: Kielce
country: Poland
facility: Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
city: Kościerzyna
country: Poland
facility: Szpital Specjalistyczny w Kościerzynie
city: Kraków
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Pabianice
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
city: Poznań
country: Poland
facility: Zakład Opieki Zdrowotnej Poznań - Stare Miasto
city: Pruszków
country: Poland
facility: Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
city: Rybnik
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
city: Siedlce
country: Poland
facility: Wojewódzki Szpital Specjalistyczny W Siedlcach
city: Szczecin
country: Poland
facility: Pomorska Akademia Medyczna
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
city: Warszawa
country: Poland
facility: Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
city: Warszawa
country: Poland
facility: Centrum Onkologii im. Marii Skodowskiej-Curie
city: Warszawa
country: Poland
facility: Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
city: Wrocław
country: Poland
facility: Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
city: Wrocław
country: Poland
facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
Study officials:
affiliation: Spectrum Pharmaceuticals, Inc
name: Shanta Chawla, MD
role: STUDY_DIRECTOR
References: