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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
January 11, 2008
January 23, 2008
July 14, 2017
August 15, 2017
November 10, 2017
August 2007
January 2012   (Final data collection date for primary outcome measure)
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.
To evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin(r) versus those who receive TUR-BT plus placebo. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00598806 on ClinicalTrials.gov Archive Site
  • 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.
  • To evaluate time to first recurrence in patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin(r) versus those who receive TUR-BT plus placebo. [ Time Frame: 2 years ]
  • To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. [ Time Frame: 2 years ]
  • To assess the safety of EOquin instilled into the bladder in the early postoperative period. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bladder Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
812
January 2012
January 2012   (Final data collection date for primary outcome measure)

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?
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Poland,   United States
 
 
NCT00598806
SPI-612
No
Not Provided
Not Provided
Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
Not Provided
Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
Spectrum Pharmaceuticals, Inc
October 2017

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