Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

Last updated: October 10, 2017
Sponsor: Spectrum Pharmaceuticals, Inc
Overall Status: Completed

Phase

3

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT00598806
SPI-612
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: All of the following questions must be answered "Yes" in order for the patient toparticipate 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 clinicallyapparent tumor Ta, grade G1-G2?

  4. If the patient is a female of childbearing potential, is she using anacceptable/effective method of contraception?

  5. If the patient is a female of childbearing potential, has she had a negative serumpregnancy test within the past 14 days?

  6. Is the patient willing and able to abide by the protocol?

Exclusion

Exclusion Criteria: All of the following questions must be answered "No" in order for the patient toparticipate 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 previousdiagnosis 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 beother 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 histologyother 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 forhim/her to undergo TURBT under general or spinal anesthesia?

  11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophilcount < 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 4months?

Study Design

Total Participants: 812
Study Start date:
August 01, 2007
Estimated Completion Date:
January 31, 2012

Study 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.

Connect with a study center

  • Prostate Cancer Institute

    Calgary, Alberta T2V4R6
    Canada

    Site Not Available

  • Lintor Medical, Inc.

    North Vancouver, British Columbia V7L2P7
    Canada

    Site Not Available

  • Andreou Research

    Surrey, British Columbia V3V1N1
    Canada

    Site Not Available

  • Can-Med Clinical Research, Inc

    Victoria, British Columbia V8T5G1
    Canada

    Site Not Available

  • G. Steinhoff Clinical Research

    Victoria, British Columbia V8V3N1
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia B3H2Y9
    Canada

    Site Not Available

  • The Male/Female Health and Research Center - Royal Court Medical Centre

    Barrie, Ontario L4M7G1
    Canada

    Site Not Available

  • Brantford Urology Research

    Brantford, Ontario N3R4N3
    Canada

    Site Not Available

  • G. Kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario L7N3V2
    Canada

    Site Not Available

  • Urology Resource Centre

    Burlington, Ontario L7S1V2
    Canada

    Site Not Available

  • Kingston General Hospital / Queen's University

    Kingston, Ontario K7L3J7
    Canada

    Site Not Available

  • Urology Associates, Urologic Medical Research

    Kitchener, Ontario N2N2B9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A5W9
    Canada

    Site Not Available

  • Mor Urology, Inc.

    Newmarket, Ontario L3X1W1
    Canada

    Site Not Available

  • Dr. Bernard Goldfarb

    North Bay, Ontario P1B7K8
    Canada

    Site Not Available

  • Stanley Flax Medical Professional Corporation

    North York, Ontario M3B3S6
    Canada

    Site Not Available

  • The Fe/Male Health Centre

    Oakville, Ontario L6H3P1
    Canada

    Site Not Available

  • Orillia Urology Associates

    Orillia, Ontario L3V7V1
    Canada

    Site Not Available

  • Urotec

    Oshawa, Ontario L1H7K4
    Canada

    Site Not Available

  • ADA Medical Ltd.

    Peterborough, Ontario K9J7B3
    Canada

    Site Not Available

  • AGT Research

    Scarborough, Ontario M1P2T7
    Canada

    Site Not Available

  • Urology & Male Infertility

    Scarborough, Ontario M1S4V5
    Canada

    Site Not Available

  • Saint Joseph Health Center

    Toronto, Ontario M6S4W4
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • The Male Health Centre

    Toronto, Ontario M6A3B5
    Canada

    Site Not Available

  • Toronto East General Hospital

    Toronto, Ontario M4C5T2
    Canada

    Site Not Available

  • University Health Network Princess Margaret Hospital

    Toronto, Ontario M5G2M9
    Canada

    Site Not Available

  • UroLaval

    Laval, Quebec H7G2E6
    Canada

    Site Not Available

  • McGill Urology Associates

    Montreal, Quebec H3G1A4
    Canada

    Site Not Available

  • Ultra-Med, Inc.

    Pointe Clare, Quebec H9R4S3
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec J1H5N4
    Canada

    Site Not Available

  • Centre hospitalier universitaire de Quebec

    Quebec, G1R3S3
    Canada

    Site Not Available

  • Uniwersytecki Szpital Kliniczny

    Białystok, 15-276
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny

    Białystok, 15-276
    Poland

    Site Not Available

  • Szpital Wojewódzki w Bielsku-BiaÅ‚ej

    Bielsko-Biała, 43-316
    Poland

    Site Not Available

  • Szpital Wojewódzki w Bielsku-Białej

    Bielsko-Biała, 43-316
    Poland

    Site Not Available

  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w GdaÅ„sku

    Gdańsk, 80-402
    Poland

    Site Not Available

  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku

    Gdańsk, 80-402
    Poland

    Site Not Available

  • Publiczny Specjalistyczny ZakÅ‚ad Opieki Zdrowotnej w InowrocÅ‚awiu

    Inowrocław, 88-100
    Poland

    Site Not Available

  • Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu

    Inowrocław, 88-100
    Poland

    Site Not Available

  • Szpital Miejski im. Prof. E. Michałowskiego

    Katowice, 40-073
    Poland

    Site Not Available

  • Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Kielce, 25-734
    Poland

    Site Not Available

  • Szpital Specjalistyczny w KoÅ›cierzynie

    Kościerzyna, 83-400
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Kościerzynie

    Kościerzyna, 83-400
    Poland

    Site Not Available

  • Niepubliczny ZakÅ‚ad Opieki Zdrowotnej "RacÅ‚awicka"

    Kraków, 30-017
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"

    Kraków, 30-017
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954
    Poland

    Site Not Available

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach

    Pabianice, 95-200
    Poland

    Site Not Available

  • ZakÅ‚ad Opieki Zdrowotnej PoznaÅ„ - Stare Miasto

    Poznań, 61-285
    Poland

    Site Not Available

  • Zakład Opieki Zdrowotnej Poznań - Stare Miasto

    Poznań, 61-285
    Poland

    Site Not Available

  • Szpital Kolejowy im. Dr med.. WÅ‚odzimierza Roeflera w Pruszkowie

    Pruszków, 05-800
    Poland

    Site Not Available

  • Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie

    Pruszków, 05-800
    Poland

    Site Not Available

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3

    Rybnik, 44-200
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny W Siedlcach

    Siedlce, 08-110
    Poland

    Site Not Available

  • Pomorska Akademia Medyczna

    Szczecin, 70-111
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny im Janusza Korczaka

    SÅ‚upsk, 76-200
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny im Janusza Korczaka

    Słupsk, 76-200
    Poland

    Site Not Available

  • Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego

    Warszawa, 00-416
    Poland

    Site Not Available

  • Centrum Onkologii im. Marii Skodowskiej-Curie

    Warszawa, 02-781
    Poland

    Site Not Available

  • Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie

    Warszawa, 04-749
    Poland

    Site Not Available

  • Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń

    Warszawa, 02-005
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON

    Warszawa, 00-909
    Poland

    Site Not Available

  • Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we WrocÅ‚awiu

    Wrocław, 50-556
    Poland

    Site Not Available

  • Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu

    Wrocław, 50-556
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy

    Wrocław, 51-124
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów

    Łódź, 90-549
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów

    Łódź, 90-549
    Poland

    Site Not Available

  • Advanced Urology Medical Center Clinical Trials

    Anaheim, California 92801
    United States

    Site Not Available

  • Hal J. Bashein, D.O.

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Urology Enterprises

    Marietta, Georgia 30060
    United States

    Site Not Available

  • North Fulton Urology

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Hines VA Hospital

    Hines, Illinois 60141
    United States

    Site Not Available

  • The Urology Center

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Towson, Maryland 21204
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • PharmaTrials, Inc.

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • PharmaTrials, Inc. - Male & Female Urology

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • Medical & Clinical Research Associates, LLC

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Urology Associates, PC

    Manhasset, New York 11030
    United States

    Site Not Available

  • North Shore - LIJ Health System - The Arthur Smith Institute for Urology

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Alliance Urology Specialists

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Piedmont Medical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Center for Urologic Care

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Medical University of South Carolina, Dept. of Urology

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Urology Associates of South Texas

    McAllen, Texas 78503
    United States

    Site Not Available

  • Salt Lake Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Adult and Pediatric Urologists

    Alexandria, Virginia 22304
    United States

    Site Not Available

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