Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

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-612)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598806
• Other study ID #: SPI-612
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2008
• Last updated: October 10, 2017
• Start date: August 2007
• Est. completion date: January 2012

Study information

• Verified date: October 2017
• 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: 812
• 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 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?

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
Canada	The Male/Female Health and Research Center - Royal Court Medical Centre	Barrie	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	G. Kenneth Jansz Medicine Professional Corporation	Burlington	Ontario
Canada	Urology Resource Centre	Burlington	Ontario
Canada	Prostate Cancer Institute	Calgary	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Kingston General Hospital / Queen's University	Kingston	Ontario
Canada	Urology Associates, Urologic Medical Research	Kitchener	Ontario
Canada	UroLaval	Laval	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	McGill Urology Associates	Montreal	Quebec
Canada	Mor Urology, Inc.	Newmarket	Ontario
Canada	Dr. Bernard Goldfarb	North Bay	Ontario
Canada	Lintor Medical, Inc.	North Vancouver	British Columbia
Canada	Stanley Flax Medical Professional Corporation	North York	Ontario
Canada	The Fe/Male Health Centre	Oakville	Ontario
Canada	Orillia Urology Associates	Orillia	Ontario
Canada	Urotec	Oshawa	Ontario
Canada	ADA Medical Ltd.	Peterborough	Ontario
Canada	Ultra-Med, Inc.	Pointe Clare	Quebec
Canada	Centre hospitalier universitaire de Quebec	Quebec
Canada	AGT Research	Scarborough	Ontario
Canada	Urology & Male Infertility	Scarborough	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Andreou Research	Surrey	British Columbia
Canada	Saint Joseph Health Center	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The Male Health Centre	Toronto	Ontario
Canada	Toronto East General Hospital	Toronto	Ontario
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario
Canada	Can-Med Clinical Research, Inc	Victoria	British Columbia
Canada	G. Steinhoff Clinical Research	Victoria	British Columbia
Poland	Uniwersytecki Szpital Kliniczny	Bialystok
Poland	Szpital Wojewódzki w Bielsku-Bialej	Bielsko-Biala
Poland	Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku	Gdansk
Poland	Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej w Inowroclawiu	Inowroclaw
Poland	Szpital Miejski im. Prof. E. Michalowskiego	Katowice
Poland	Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Kielce
Poland	Szpital Specjalistyczny w Koscierzynie	Koscierzyna
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Raclawicka"	Kraków
Poland	Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi - Centralny Szpital Weteranów	Lódz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Pabianicach	Pabianice
Poland	Zaklad Opieki Zdrowotnej Poznan - Stare Miasto	Poznan
Poland	Szpital Kolejowy im. Dr med.. Wlodzimierza Roeflera w Pruszkowie	Pruszków
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3	Rybnik
Poland	Wojewódzki Szpital Specjalistyczny W Siedlcach	Siedlce
Poland	Wojewódzki Szpital Specjalistyczny im Janusza Korczaka	Slupsk
Poland	Pomorska Akademia Medyczna	Szczecin
Poland	Centrum Medycznego Ksztalcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orlowskiego	Warszawa
Poland	Centrum Onkologii im. Marii Skodowskiej-Curie	Warszawa
Poland	Fundacja "Urologia", Miedzyleski Szpital Specjalistyczny w Warszawie	Warszawa
Poland	Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen	Warszawa
Poland	Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON	Warszawa
Poland	Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Poland	Wojewódzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo Rozwojowy	Wroclaw
United States	Adult and Pediatric Urologists	Alexandria	Virginia
United States	Advanced Urology Medical Center Clinical Trials	Anaheim	California
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Medical & Clinical Research Associates, LLC	Bay Shore	New York
United States	Center for Urologic Care	Bryn Mawr	Pennsylvania
United States	Medical University of South Carolina, Dept. of Urology	Charleston	South Carolina
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	PharmaTrials, Inc.	Hillsborough	New Jersey
United States	PharmaTrials, Inc. - Male & Female Urology	Hillsborough	New Jersey
United States	Hines VA Hospital	Hines	Illinois
United States	Urology Associates, PC	Manhasset	New York
United States	Urology Enterprises	Marietta	Georgia
United States	Urology Associates of South Texas	McAllen	Texas
United States	North Shore - LIJ Health System - The Arthur Smith Institute for Urology	New Hyde Park	New York
United States	North Fulton Urology	Roswell	Georgia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Salt Lake Research	Salt Lake City	Utah
United States	The Urology Center	Slidell	Louisiana
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Hal J. Bashein, D.O.	West Palm Beach	Florida
United States	Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

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