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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461591
First Posted: April 18, 2007
Last Update Posted: August 15, 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-611)

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 proportion of patients 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 proportion of patients 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: 802
Actual Study Start Date: April 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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?
  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): NCT00461591


  Show 74 Study Locations
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: NCT00461591     History of Changes
Other Study ID Numbers: SPI-611
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: July 14, 2017
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: July 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


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