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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598806
First Posted: January 23, 2008
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
  Purpose
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.

Condition Intervention Phase
Bladder Cancer Drug: Apaziquone Drug: Placebo Procedure: TURBT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Recurrence Rate at 2 Years [ Time Frame: 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:
  • Time to Recurrence [ Time Frame: 2 years ]
    The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.

  • Progression Rate at 2 Years [ Time Frame: 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 [ Time Frame: 2 years ]
    The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.

  • Number of Recurrences Per Patient [ Time Frame: 2 years ]
    The number of histologically confirmed recurrences during the course of the study.

  • Disease-Free Interval [ Time Frame: 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 [ Time Frame: 2 years ]
    The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause

  • Overall Survival [ Time Frame: 2 years ]
    The number of months from randomization to death from any cause.


Enrollment: 812
Actual Study Start Date: August 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apaziquone
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Drug: Apaziquone
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Other Name: EOquin®, Qapzola
Procedure: TURBT
TransUrethral Resection of the Bladder Tumor
Placebo Comparator: Placebo
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Drug: Placebo
A single intravesical dose of placebo instilled into the bladder post-TURBT
Procedure: TURBT
TransUrethral Resection of the Bladder Tumor

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598806


  Hide Study Locations
Locations
United States, California
Advanced Urology Medical Center Clinical Trials
Anaheim, California, United States, 92801
United States, Florida
Hal J. Bashein, D.O.
West Palm Beach, Florida, United States, 33407
United States, Georgia
Urology Enterprises
Marietta, Georgia, United States, 30060
North Fulton Urology
Roswell, Georgia, United States, 30076
United States, Illinois
Hines VA Hospital
Hines, Illinois, United States, 60141
United States, Louisiana
The Urology Center
Slidell, Louisiana, United States, 70458
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
PharmaTrials, Inc. - Male & Female Urology
Hillsborough, New Jersey, United States, 08844
PharmaTrials, Inc.
Hillsborough, New Jersey, United States, 08844
United States, New York
Medical & Clinical Research Associates, LLC
Bay Shore, New York, United States, 11706
Urology Associates, PC
Manhasset, New York, United States, 11030
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
New Hyde Park, New York, United States, 11040
United States, North Carolina
Alliance Urology Specialists
Greensboro, North Carolina, United States, 27403
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
Medical University of South Carolina, Dept. of Urology
Charleston, South Carolina, United States, 29425
United States, Texas
Urology Associates of South Texas
McAllen, Texas, United States, 78503
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Adult and Pediatric Urologists
Alexandria, Virginia, United States, 22304
Canada, Alberta
Prostate Cancer Institute
Calgary, Alberta, Canada, T2V4R6
Canada, British Columbia
Lintor Medical, Inc.
North Vancouver, British Columbia, Canada, V7L2P7
Andreou Research
Surrey, British Columbia, Canada, V3V1N1
Can-Med Clinical Research, Inc
Victoria, British Columbia, Canada, V8T5G1
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V3N1
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
The Male/Female Health and Research Center - Royal Court Medical Centre
Barrie, Ontario, Canada, L4M7G1
Brantford Urology Research
Brantford, Ontario, Canada, N3R4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N3V2
Urology Resource Centre
Burlington, Ontario, Canada, L7S1V2
Kingston General Hospital / Queen's University
Kingston, Ontario, Canada, K7L3J7
Urology Associates, Urologic Medical Research
Kitchener, Ontario, Canada, N2N2B9
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Mor Urology, Inc.
Newmarket, Ontario, Canada, L3X1W1
Dr. Bernard Goldfarb
North Bay, Ontario, Canada, P1B7K8
Stanley Flax Medical Professional Corporation
North York, Ontario, Canada, M3B3S6
The Fe/Male Health Centre
Oakville, Ontario, Canada, L6H3P1
Orillia Urology Associates
Orillia, Ontario, Canada, L3V7V1
Urotec
Oshawa, Ontario, Canada, L1H7K4
ADA Medical Ltd.
Peterborough, Ontario, Canada, K9J7B3
AGT Research
Scarborough, Ontario, Canada, M1P2T7
Urology & Male Infertility
Scarborough, Ontario, Canada, M1S4V5
Toronto East General Hospital
Toronto, Ontario, Canada, M4C5T2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
The Male Health Centre
Toronto, Ontario, Canada, M6A3B5
Saint Joseph Health Center
Toronto, Ontario, Canada, M6S4W4
Canada, Quebec
UroLaval
Laval, Quebec, Canada, H7G2E6
McGill Urology Associates
Montreal, Quebec, Canada, H3G1A4
Ultra-Med, Inc.
Pointe Clare, Quebec, Canada, H9R4S3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Canada
Centre hospitalier universitaire de Quebec
Quebec, Canada, G1R3S3
Poland
Uniwersytecki Szpital Kliniczny
Białystok, Poland, 15-276
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biała, Poland, 43-316
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
Gdańsk, Poland, 80-402
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
Inowrocław, Poland, 88-100
Szpital Miejski im. Prof. E. Michałowskiego
Katowice, Poland, 40-073
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce, Poland, 25-734
Szpital Specjalistyczny w Kościerzynie
Kościerzyna, Poland, 83-400
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
Kraków, Poland, 30-017
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland, 20-954
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
Pabianice, Poland, 95-200
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
Poznań, Poland, 61-285
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
Pruszków, Poland, 05-800
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
Rybnik, Poland, 44-200
Wojewódzki Szpital Specjalistyczny W Siedlcach
Siedlce, Poland, 08-110
Pomorska Akademia Medyczna
Szczecin, Poland, 70-111
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, Poland, 76-200
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warszawa, Poland, 00-416
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warszawa, Poland, 00-909
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
Warszawa, Poland, 02-005
Centrum Onkologii im. Marii Skodowskiej-Curie
Warszawa, Poland, 02-781
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
Warszawa, Poland, 04-749
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
Wrocław, Poland, 50-556
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
Wrocław, Poland, 51-124
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
Łódź, Poland, 90-549
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
  More Information

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00598806     History of Changes
Other Study ID Numbers: SPI-612
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: July 14, 2017
Results First Posted: August 15, 2017
Last Update Posted: November 10, 2017
Last Verified: October 2017

Keywords provided by Spectrum Pharmaceuticals, Inc:
Noninvasive Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Apaziquone
Antineoplastic Agents