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

Bladder Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461591
• Other study ID #: SPI-611
• Status: Completed
• Phase: Phase 3
• Start date: April 2007
• Est. completion date: January 2012

Study information

• Verified date: March 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Apaziquone
A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
• Placebo
A single intravesical dose of placebo instilled into the bladder post-TURBT

Procedure:
• TURBT
TransUrethral Resection of the Bladder Tumor

Locations

Country	Name	City	State
United States	Capital Region Urological Surgeons	Albany	New York
United States	The Urological Institute of NE NY	Albany	New York
United States	Urology Group of New Mexico	Albuquerque	New Mexico
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	Anne Arundel Urology	Annapolis	Maryland
United States	Urologic Consultants of South Eastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Coastal Urological Associates, PA	Brick	New Jersey
United States	Urology Associates Medical Group	Burbank	California
United States	Adult and Pediatric Urology	Carmel	New York
United States	University of Chicago	Chicago	Illinois
United States	TriState Urologic Services PSC, Inc.	Cincinnati	Ohio
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Columbus Urology Research, LLC	Columbus	Ohio
United States	Corpus Christi Urology Group LLC	Corpus Christi	Texas
United States	Urology Clinics of North Texas	Dallas	Texas
United States	The Urology Center of Colorado	Denver	Colorado
United States	Northeast Indiana Research, LLC	Fort Wayne	Indiana
United States	Mary Washington Hospital and Urology Associates of Fredericksburg	Fredericksburg	Virginia
United States	Urology Associates of Central CA	Fresno	California
United States	Gainesville Urology, PC	Gainesville	Georgia
United States	Accumed Research Associates	Garden City	New York
United States	Urological Surgeons of Long Island, P.C.	Garden City	New York
United States	The Conrad Pearson Clinic	Germantown	Tennessee
United States	MMPC Urology	Grand Rapids	Michigan
United States	Myron Murdock, MD, LLC	Greenbelt	Maryland
United States	Metropolitan Urology	Jeffersonville	Indiana
United States	Hudson Valley Urology, PC	Kingston	New York
United States	South Orange County Medical Research Center	Laguna Woods	California
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Urological Associates of Lancaster	Lancaster	Pennsylvania
United States	AdvanceMed Research	Lawrenceville	New Jersey
United States	Urology Consultants	Longwood	Florida
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Urological Professional Association	Macon	Georgia
United States	Delaware Valley Urology, LLC-Marlton	Marlton	New Jersey
United States	Urology Associates, SC	Mattoon	Illinois
United States	Idaho Urologic Institute, P.A.	Meridian	Idaho
United States	University of Miami	Miami	Florida
United States	Connecticut Clinical Research Center	Middlebury	Connecticut
United States	Five Valleys Urology	Missoula	Montana
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Advanced Research Institute	New Port Richey	Florida
United States	Advanced Research Institute	New Port Richey	Florida
United States	University Urology Associates	New York	New York
United States	Urology of Virginia, PC	Norfolk	Virginia
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	CNY Urology, PC	Oneida	New York
United States	Cancer Research Dept/St. Joseph Hospital	Orange	California
United States	Kansas City Urology Care, P.A.	Overland Park	Kansas
United States	Speciality Care Research	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	BCG Oncology	Phoenix	Arizona
United States	Triangle Urology Group	Pittsburgh	Pennsylvania
United States	Hudson Valley Urology	Poughkeepsie	New York
United States	Urology Associates of Rochester, LLC	Rochester	New York
United States	Lakeside Urology, PC	Saint Joseph	Michigan
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Bernardino Urologic Association	San Bernardino	California
United States	VA Medical Center	San Francisco	California
United States	Florida Urology Specialists	Sarasota	Florida
United States	Seattle Urological Associates	Seattle	Washington
United States	Deleware Valley Urology, LLC-Washington Township	Sewell	New Jersey
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Oregon Urology Institute	Springfield	Oregon
United States	Sun Health Research Institute	Sun City	Arizona
United States	Southeastern Research Group, Inc.	Tallahassee	Florida
United States	Michigan Institute of Urology, PC	Troy	Michigan
United States	Urology of Virginia, PC	Virginia Beach	Virginia
United States	Delaware Valley Urology, LLC - Voorhees	Voorhees	New Jersey
United States	Urologic Surgeons of Washington	Washington	District of Columbia
United States	Delaware Valley Urology, LLC-Westampton	Westampton	New Jersey
United States	Susquehenna Urology	Williamsport	Pennsylvania
United States	Center for Urologic Research of WNY, LLC	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Time to Recurrence	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.	2 years
Secondary	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.	2 years
Secondary	Time to Progression	The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.	2 years
Secondary	Number of Recurrences Per Patient	The number of histologically confirmed recurrences during the course of the study.	2 years
Secondary	Disease Free Interval	The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause	2 years
Secondary	Disease Free Survival	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause	2 years
Secondary	Overall Survival	The number of months from randomization to death from any cause.	2 years