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Bladder CancerPhase 3NCT00461591

Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

A Phase 3 study testing Apaziquone and TURBT in people with Bladder Cancer, run by Spectrum Pharmaceuticals, Inc at 74 sites in United States.

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
802 participants
Where
74 sitesUnited States
Study dates
Apr 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

  • 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 stage 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

  • Does the patient have more than 4 bladder tumors?
  • Does any single bladder tumor exceed 3.5 cm in diameter?
  • Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
  • Has the patient ever received Apaziquone?
  • Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage 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?
Show all 17Show fewer
  • 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 10^9/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 a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
  • 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

74 sites in 1 country.

74 sites in 1 country

United States74 sites

  • Capital Region Urological Surgeons

    Albany, New York, 12208

  • The Urological Institute of NE NY

    Albany, New York, 12208

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Alaska Clinical Research Center, LLC

    Anchorage, Alaska, 99508

  • Anne Arundel Urology

    Annapolis, Maryland, 21401

  • Urologic Consultants of South Eastern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19026

  • Coastal Urological Associates, PA

    Brick, New Jersey, 08724

  • Urology Associates Medical Group

    Burbank, California, 91505

  • Adult and Pediatric Urology

    Carmel, New York, 10512

  • University of Chicago

    Chicago, Illinois, 60637

  • TriState Urologic Services PSC, Inc.

    Cincinnati, Ohio, 45212

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Columbus Urology Research, LLC

    Columbus, Ohio, 43220

  • Corpus Christi Urology Group LLC

    Corpus Christi, Texas, 78404

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Northeast Indiana Research, LLC

    Fort Wayne, Indiana, 46825

  • Mary Washington Hospital and Urology Associates of Fredericksburg

    Fredericksburg, Virginia, 22401

  • Urology Associates of Central CA

    Fresno, California, 93720

  • Gainesville Urology, PC

    Gainesville, Georgia, 30501

  • Accumed Research Associates

    Garden City, New York, 11530

  • Urological Surgeons of Long Island, P.C.

    Garden City, New York, 11530

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

  • MMPC Urology

    Grand Rapids, Michigan, 49546

  • Myron Murdock, MD, LLC

    Greenbelt, Maryland, 20770

  • Metropolitan Urology

    Jeffersonville, Indiana, 47130

  • Hudson Valley Urology, PC

    Kingston, New York, 12401

  • South Orange County Medical Research Center

    Laguna Woods, California, 92653

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Urology Consultants

    Longwood, Florida, 32750

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Urological Professional Association

    Macon, Georgia, 31217

  • Delaware Valley Urology, LLC-Marlton

    Marlton, New Jersey, 08053

  • Urology Associates, SC

    Mattoon, Illinois, 61938

  • Idaho Urologic Institute, P.A.

    Meridian, Idaho, 83642

  • University of Miami

    Miami, Florida, 33136

  • Connecticut Clinical Research Center

    Middlebury, Connecticut, 06762

  • Five Valleys Urology

    Missoula, Montana, 59802

  • Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • Advanced Research Institute

    New Port Richey, Florida, 34655

  • University Urology Associates

    New York, New York, 10016

  • Urology of Virginia, PC

    Norfolk, Virginia, 23502

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • CNY Urology, PC

    Oneida, New York, 13421

  • Cancer Research Dept/St. Joseph Hospital

    Orange, California, 92868

  • Kansas City Urology Care, P.A.

    Overland Park, Kansas, 66211

  • Speciality Care Research

    Peoria, Illinois, 61614

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • BCG Oncology

    Phoenix, Arizona, 85032

  • Triangle Urology Group

    Pittsburgh, Pennsylvania, 15212

  • Hudson Valley Urology

    Poughkeepsie, New York, 12601

  • Urology Associates of Rochester, LLC

    Rochester, New York, 14618

  • Lakeside Urology, PC

    Saint Joseph, Michigan, 49085

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • San Bernardino Urologic Association

    San Bernardino, California, 92404

  • VA Medical Center

    San Francisco, California, 94121

  • Florida Urology Specialists

    Sarasota, Florida, 34237

  • Seattle Urological Associates

    Seattle, Washington, 98104

  • Deleware Valley Urology, LLC-Washington Township

    Sewell, New Jersey, 08080

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Sun Health Research Institute

    Sun City, Arizona, 85032

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

  • Michigan Institute of Urology, PC

    Troy, Michigan, 48084

  • Urology of Virginia, PC

    Virginia Beach, Virginia, 23454

  • Delaware Valley Urology, LLC - Voorhees

    Voorhees Township, New Jersey, 08043

  • Urologic Surgeons of Washington

    Washington D.C., District of Columbia, 20006

  • Susquehenna Urology

    Williamsport, Pennsylvania, 17701

  • Center for Urologic Research of WNY, LLC

    Williamsville, New York, 14221

  • Delaware Valley Urology, LLC-Westampton

    Woodlane, New Jersey, 08060

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-611)

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 NCT00461591
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 posted18 Apr 2007 (estimated)
  2. Study startApr 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
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461591
Sponsor's protocol ID
SPI-611
Status last verified
Mar 2021
First submitted
16 Apr 2007
Last updated
30 Mar 2021
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 74 sites in United States.

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 6 inclusion and 17 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in 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 NCT00461591.

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 30 Mar 2021.

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