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

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ClinicalTrials.gov Identifier: NCT00461591
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : August 15, 2017
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE April 16, 2007
First Posted Date  ICMJE April 18, 2007
Results First Submitted Date  ICMJE July 14, 2017
Results First Posted Date  ICMJE August 15, 2017
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE April 2007
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
Recurrence Rate at 2 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
  • Time to Recurrence
  • Progression to Higher Stage or Grade
  • Number of Recurrences per Patient
  • Disease Free Interval
  • Disease Free Survival
  • Overall Survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • Drug: Apaziquone
    A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
    Other Name: EOquin®, Qapzola
  • Drug: Placebo
    A single intravesical dose of placebo instilled into the bladder post-TURBT
  • Procedure: TURBT
    TransUrethral Resection of the Bladder Tumor
Study Arms  ICMJE
  • Experimental: Apaziquone
    TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
    Interventions:
    • Drug: Apaziquone
    • Procedure: TURBT
  • Placebo Comparator: Placebo
    TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
    Interventions:
    • Drug: Placebo
    • Procedure: TURBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2012)
802
Original Enrollment  ICMJE
 (submitted: April 17, 2007)
674
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: (All questions must be answered YES)

  • 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?

Exclusion Criteria: (All questions must be answered NO)

  • 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?
  • 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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00461591
Other Study ID Numbers  ICMJE SPI-611
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Spectrum Pharmaceuticals, Inc
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP