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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apaziquone
Placebo
TURBT
Sponsored by
Spectrum Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Noninvasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?

Sites / Locations

  • Alaska Clinical Research Center, LLC
  • BCG Oncology
  • Sun Health Research Institute
  • Urology Associates Medical Group
  • Urology Associates of Central CA
  • South Orange County Medical Research Center
  • Kaiser Permanente Los Angeles Medical Center
  • Cancer Research Dept/St. Joseph Hospital
  • San Bernardino Urologic Association
  • VA Medical Center
  • The Urology Center of Colorado
  • Connecticut Clinical Research Center
  • Urologic Surgeons of Washington
  • Lakeland Regional Cancer Center
  • Urology Consultants
  • University of Miami
  • Advanced Research Institute
  • Advanced Research Institute
  • Florida Foundation for Healthcare Research
  • Florida Urology Specialists
  • Southeastern Research Group, Inc.
  • Gainesville Urology, PC
  • Urological Professional Association
  • North Idaho Urology
  • Idaho Urologic Institute, P.A.
  • University of Chicago
  • Urology Associates, SC
  • Speciality Care Research
  • Northeast Indiana Research, LLC
  • Metropolitan Urology
  • Kansas City Urology Care, P.A.
  • Regional Urology, LLC
  • Anne Arundel Urology
  • Myron Murdock, MD, LLC
  • MMPC Urology
  • Lakeside Urology, PC
  • Michigan Institute of Urology, PC
  • Five Valleys Urology
  • Coastal Urological Associates, PA
  • AdvanceMed Research
  • Delaware Valley Urology, LLC-Marlton
  • Deleware Valley Urology, LLC-Washington Township
  • Delaware Valley Urology, LLC - Voorhees
  • Delaware Valley Urology, LLC-Westampton
  • Urology Group of New Mexico
  • Capital Region Urological Surgeons
  • The Urological Institute of NE NY
  • Adult and Pediatric Urology
  • Accumed Research Associates
  • Urological Surgeons of Long Island, P.C.
  • Hudson Valley Urology, PC
  • University Urology Associates
  • CNY Urology, PC
  • Hudson Valley Urology
  • Urology Associates of Rochester, LLC
  • Center for Urologic Research of WNY, LLC
  • TriState Urologic Services PSC, Inc.
  • Columbus Urology Research, LLC
  • Oregon Urology Institute
  • Urologic Consultants of South Eastern Pennsylvania
  • Urological Associates of Lancaster
  • Fox Chase Cancer Center
  • Triangle Urology Group
  • Susquehenna Urology
  • Carolina Urologic Research Center
  • The Conrad Pearson Clinic
  • Corpus Christi Urology Group LLC
  • Urology Clinics of North Texas
  • Urology San Antonio Research
  • Mary Washington Hospital and Urology Associates of Fredericksburg
  • Urology of Virginia, PC
  • Urology of Virginia, PC
  • Integrity Medical Research, LLC
  • Seattle Urological Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apaziquone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Recurrence
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
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.
Time to Progression
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
The number of histologically confirmed recurrences during the course of the study.
Disease Free Interval
The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Disease Free Survival
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Overall Survival
The number of months from randomization to death from any cause.

Full Information

First Posted
April 16, 2007
Last Updated
March 9, 2021
Sponsor
Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00461591
Brief Title
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2007 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Noninvasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
802 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apaziquone
Arm Type
Experimental
Arm Description
TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Intervention Type
Drug
Intervention Name(s)
Apaziquone
Other Intervention Name(s)
EOquin®, Qapzola
Intervention Description
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single intravesical dose of placebo instilled into the bladder post-TURBT
Intervention Type
Procedure
Intervention Name(s)
TURBT
Intervention Description
TransUrethral Resection of the Bladder Tumor
Primary Outcome Measure Information:
Title
Recurrence Rate at 2 Years
Description
The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Time to Recurrence
Description
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.
Time Frame
2 years
Title
Progression Rate at 2 Years
Description
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 Frame
2 years
Title
Time to Progression
Description
The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Time Frame
2 years
Title
Number of Recurrences Per Patient
Description
The number of histologically confirmed recurrences during the course of the study.
Time Frame
2 years
Title
Disease Free Interval
Description
The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Time Frame
2 years
Title
Disease Free Survival
Description
The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Time Frame
2 years
Title
Overall Survival
Description
The number of months from randomization to death from any cause.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanta Chawla, MD
Organizational Affiliation
Spectrum Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
BCG Oncology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Urology Associates Medical Group
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Urology Associates of Central CA
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Cancer Research Dept/St. Joseph Hospital
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
San Bernardino Urologic Association
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Urologic Surgeons of Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Urology Consultants
City
Longwood
State/Province
Florida
ZIP/Postal Code
32750
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Urology Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Southeastern Research Group, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Gainesville Urology, PC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Urological Professional Association
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
North Idaho Urology
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Idaho Urologic Institute, P.A.
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Urology Associates, SC
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Speciality Care Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Kansas City Urology Care, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Anne Arundel Urology
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Myron Murdock, MD, LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
MMPC Urology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Lakeside Urology, PC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Michigan Institute of Urology, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Five Valleys Urology
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Coastal Urological Associates, PA
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Delaware Valley Urology, LLC-Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Deleware Valley Urology, LLC-Washington Township
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Delaware Valley Urology, LLC - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Delaware Valley Urology, LLC-Westampton
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Capital Region Urological Surgeons
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
The Urological Institute of NE NY
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Adult and Pediatric Urology
City
Carmel
State/Province
New York
ZIP/Postal Code
10512
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island, P.C.
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
CNY Urology, PC
City
Oneida
State/Province
New York
ZIP/Postal Code
13421
Country
United States
Facility Name
Hudson Valley Urology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Urology Associates of Rochester, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Center for Urologic Research of WNY, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
TriState Urologic Services PSC, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Columbus Urology Research, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43220
Country
United States
Facility Name
Oregon Urology Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Urologic Consultants of South Eastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Urological Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Triangle Urology Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Susquehenna Urology
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17701
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
The Conrad Pearson Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Corpus Christi Urology Group LLC
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Mary Washington Hospital and Urology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Urology of Virginia, PC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Urology of Virginia, PC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Seattle Urological Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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