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Bladder CancerPhase 3NCT00598806

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

A Phase 3 study testing Apaziquone and TURBT in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 77 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Apaziquone and TURBT
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
812 participants
Where
77 sitesin 3 countries
Study dates
Aug 2007to Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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?

Who cannot join

  • 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])?
Show all 18Show fewer
  • 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?

Trial locations and contacts

77 sites in 3 countries.

77 sites in 3 countries

Canada32 sites

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

    Barrie, Ontario, L4M7G1

  • Brantford Urology Research

    Brantford, Ontario, N3R4N3

  • G. Kenneth Jansz Medicine Professional Corporation

    Burlington, Ontario, L7N3V2

  • Urology Resource Centre

    Burlington, Ontario, L7S1V2

  • Prostate Cancer Institute

    Calgary, Alberta, T2V4R6

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H2Y9

  • Kingston General Hospital / Queen's University

    Kingston, Ontario, K7L3J7

  • Urology Associates, Urologic Medical Research

    Kitchener, Ontario, N2N2B9

  • UroLaval

    Laval, Quebec, H7G2E6

  • London Health Sciences Centre

    London, Ontario, N6A5W9

  • McGill Urology Associates

    Montreal, Quebec, H3G1A4

  • Mor Urology, Inc.

    Newmarket, Ontario, L3X1W1

  • Dr. Bernard Goldfarb

    North Bay, Ontario, P1B7K8

  • Lintor Medical, Inc.

    North Vancouver, British Columbia, V7L2P7

  • Stanley Flax Medical Professional Corporation

    North York, Ontario, M3B3S6

  • The Fe/Male Health Centre

    Oakville, Ontario, L6H3P1

  • Orillia Urology Associates

    Orillia, Ontario, L3V7V1

  • Urotec

    Oshawa, Ontario, L1H7K4

  • ADA Medical Ltd.

    Peterborough, Ontario, K9J7B3

  • Ultra-Med, Inc.

    Pointe Clare, Quebec, H9R4S3

  • Centre hospitalier universitaire de Quebec

    Québec, G1R3S3

  • AGT Research

    Scarborough Village, Ontario, M1P2T7

  • Urology & Male Infertility

    Scarborough Village, Ontario, M1S4V5

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H5N4

  • Andreou Research

    Surrey, British Columbia, V3V1N1

  • Toronto East General Hospital

    Toronto, Ontario, M4C5T2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

  • University Health Network Princess Margaret Hospital

    Toronto, Ontario, M5G2M9

  • The Male Health Centre

    Toronto, Ontario, M6A3B5

  • Saint Joseph Health Center

    Toronto, Ontario, M6S4W4

  • Can-Med Clinical Research, Inc

    Victoria, British Columbia, V8T5G1

  • G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V3N1

Other trials in Canada

Poland24 sites

  • Uniwersytecki Szpital Kliniczny

    Bialystok, 15-276

  • Szpital Wojewódzki w Bielsku-Białej

    Bielsko-Biala, 43-316

  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku

    Gdansk, 80-402

  • Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu

    Inowrocław, 88-100

  • Szpital Miejski im. Prof. E. Michałowskiego

    Katowice, 40-073

  • Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej

    Kielce, 25-734

  • Szpital Specjalistyczny w Kościerzynie

    Kościerzyna, 83-400

  • Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"

    Krakow, 30-017

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

    Lodz, 90-549

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach

    Pabianice, 95-200

  • Zakład Opieki Zdrowotnej Poznań - Stare Miasto

    Poznan, 61-285

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

    Pruszków, 05-800

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

    Rybnik, 44-200

  • Wojewódzki Szpital Specjalistyczny W Siedlcach

    Siedlce, 08-110

  • Wojewódzki Szpital Specjalistyczny im Janusza Korczaka

    Słupsk, 76-200

  • Pomorska Akademia Medyczna

    Szczecin, 70-111

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

    Warsaw, 00-416

  • Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON

    Warsaw, 00-909

  • Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń

    Warsaw, 02-005

  • Centrum Onkologii im. Marii Skodowskiej-Curie

    Warsaw, 02-781

  • Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 04-749

  • Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-556

  • Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy

    Wroclaw, 51-124

Other trials in Poland

United States21 sites

  • Adult and Pediatric Urologists

    Alexandria, Virginia, 22304

  • Advanced Urology Medical Center Clinical Trials

    Anaheim, California, 92801

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21237

  • Medical & Clinical Research Associates, LLC

    Bay Shore, New York, 11706

  • Center for Urologic Care

    Bryn Mawr, Pennsylvania, 19010

  • Medical University of South Carolina, Dept. of Urology

    Charleston, South Carolina, 29425

  • Alliance Urology Specialists

    Greensboro, North Carolina, 27403

  • PharmaTrials, Inc. - Male & Female Urology

    Hillsborough, New Jersey, 08844

  • PharmaTrials, Inc.

    Hillsborough, New Jersey, 08844

  • Hines VA Hospital

    Hines, Illinois, 60141

  • Urology Associates, PC

    Manhasset, New York, 11030

  • Urology Enterprises

    Marietta, Georgia, 30060

  • Urology Associates of South Texas

    McAllen, Texas, 78503

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

    New Hyde Park, New York, 11040

  • North Fulton Urology

    Roswell, Georgia, 30076

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Salt Lake Research

    Salt Lake City, Utah, 84107

  • The Urology Center

    Slidell, Louisiana, 70458

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204

  • Hal J. Bashein, D.O.

    West Palm Beach, Florida, 33407

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Bladder Cancer
Being tested
Apaziquone, Placebo, TURBT
Keywords
Noninvasive Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApaziquoneDrug

    Also called EOquin®, Qapzola

    A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

  • PlaceboDrug

    A single intravesical dose of placebo instilled into the bladder post-TURBT

  • TURBTProcedure or surgery

    TransUrethral Resection of the Bladder Tumor

Study groups in NCT00598806
Study groupRoleWhat they receive
ApaziquoneExperimentalTURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Receives: Drug: Apaziquone; Procedure: TURBT
PlaceboPlacebo comparatorTURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Receives: Drug: Placebo; Procedure: TURBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Rate at 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.

    Measured: 2 years

Secondary outcomes (7)

  1. Time to Recurrence

    The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.

    Measured: 2 years

  2. Progression Rate at 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.

    Measured: 2 years

  3. Time to Progression

    The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.

    Measured: 2 years

  4. Number of Recurrences Per Patient

    The number of histologically confirmed recurrences during the course of the study.

    Measured: 2 years

  5. Disease-Free Interval

    The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause

    Measured: 2 years

  6. Disease-Free Survival

    The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause

    Measured: 2 years

  7. Overall Survival

    The number of months from randomization to death from any cause.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00598806
Sponsor's protocol ID
SPI-612
Status last verified
Oct 2017
First submitted
11 Jan 2008
Last updated
13 Nov 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apaziquone and TURBT in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 77 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Canada, Poland, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Rate at 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00598806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.

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