Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

All of the following questions must be answered "Yes" in order for the patient to participate in the study.

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 tumor 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 of the following questions must be answered "No" in order for the patient to participate in the study.

Does the patient have more than 5 bladder tumors?
Does any single bladder tumor exceed 3.5 cm in diameter?
Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer?
Has the patient ever received EOquin(r)?
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])?
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 109/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 screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L?
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?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

812

Study ID:

NCT00598806

Recruitment Status:

Completed

Sponsor:

Spectrum Pharmaceuticals, Inc

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There are 76 Locations for this study

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Advanced Urology Medical Center Clinical Trials
Anaheim California, 92801, United States
Hal J. Bashein, D.O.
West Palm Beach Florida, 33407, United States
Urology Enterprises
Marietta Georgia, 30060, United States
North Fulton Urology
Roswell Georgia, 30076, United States
Hines VA Hospital
Hines Illinois, 60141, United States
The Urology Center
Slidell Louisiana, 70458, United States
Chesapeake Urology Research Associates
Baltimore Maryland, 21237, United States
Chesapeake Urology Research Associates
Towson Maryland, 21204, United States
William Beaumont Hospital
Royal Oak Michigan, 48073, United States
PharmaTrials, Inc. - Male & Female Urology
Hillsborough New Jersey, 08844, United States
PharmaTrials, Inc.
Hillsborough New Jersey, 08844, United States
Medical & Clinical Research Associates, LLC
Bay Shore New York, 11706, United States
Urology Associates, PC
Manhasset New York, 11030, United States
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
New Hyde Park New York, 11040, United States
Alliance Urology Specialists
Greensboro North Carolina, 27403, United States
Piedmont Medical Research
Winston-Salem North Carolina, 27103, United States
Center for Urologic Care
Bryn Mawr Pennsylvania, 19010, United States
Medical University of South Carolina, Dept. of Urology
Charleston South Carolina, 29425, United States
Urology Associates of South Texas
McAllen Texas, 78503, United States
Salt Lake Research
Salt Lake City Utah, 84107, United States
Adult and Pediatric Urologists
Alexandria Virginia, 22304, United States
Prostate Cancer Institute
Calgary Alberta, T2V4R, Canada
Lintor Medical, Inc.
North Vancouver British Columbia, V7L2P, Canada
Andreou Research
Surrey British Columbia, V3V1N, Canada
Can-Med Clinical Research, Inc
Victoria British Columbia, V8T5G, Canada
G. Steinhoff Clinical Research
Victoria British Columbia, V8V3N, Canada
Queen Elizabeth II Health Sciences Centre
Halifax Nova Scotia, B3H2Y, Canada
The Male/Female Health and Research Center - Royal Court Medical Centre
Barrie Ontario, L4M7G, Canada
Brantford Urology Research
Brantford Ontario, N3R4N, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington Ontario, L7N3V, Canada
Urology Resource Centre
Burlington Ontario, L7S1V, Canada
Kingston General Hospital / Queen's University
Kingston Ontario, K7L3J, Canada
Urology Associates, Urologic Medical Research
Kitchener Ontario, N2N2B, Canada
London Health Sciences Centre
London Ontario, N6A5W, Canada
Mor Urology, Inc.
Newmarket Ontario, L3X1W, Canada
Dr. Bernard Goldfarb
North Bay Ontario, P1B7K, Canada
Stanley Flax Medical Professional Corporation
North York Ontario, M3B3S, Canada
The Fe/Male Health Centre
Oakville Ontario, L6H3P, Canada
Orillia Urology Associates
Orillia Ontario, L3V7V, Canada
Urotec
Oshawa Ontario, L1H7K, Canada
ADA Medical Ltd.
Peterborough Ontario, K9J7B, Canada
AGT Research
Scarborough Ontario, M1P2T, Canada
Urology & Male Infertility
Scarborough Ontario, M1S4V, Canada
Toronto East General Hospital
Toronto Ontario, M4C5T, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N3M, Canada
University Health Network Princess Margaret Hospital
Toronto Ontario, M5G2M, Canada
The Male Health Centre
Toronto Ontario, M6A3B, Canada
Saint Joseph Health Center
Toronto Ontario, M6S4W, Canada
UroLaval
Laval Quebec, H7G2E, Canada
McGill Urology Associates
Montreal Quebec, H3G1A, Canada
Ultra-Med, Inc.
Pointe Clare Quebec, H9R4S, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke Quebec, J1H5N, Canada
Centre hospitalier universitaire de Quebec
Quebec , G1R3S, Canada
Uniwersytecki Szpital Kliniczny
Białystok , 15-27, Poland
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biała , 43-31, Poland
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
Gdańsk , 80-40, Poland
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
Inowrocław , 88-10, Poland
Szpital Miejski im. Prof. E. Michałowskiego
Katowice , 40-07, Poland
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce , 25-73, Poland
Szpital Specjalistyczny w Kościerzynie
Kościerzyna , 83-40, Poland
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
Kraków , 30-01, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin , 20-95, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
Pabianice , 95-20, Poland
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
Poznań , 61-28, Poland
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
Pruszków , 05-80, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
Rybnik , 44-20, Poland
Wojewódzki Szpital Specjalistyczny W Siedlcach
Siedlce , 08-11, Poland
Pomorska Akademia Medyczna
Szczecin , 70-11, Poland
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk , 76-20, Poland
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warszawa , 00-41, Poland
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warszawa , 00-90, Poland
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
Warszawa , 02-00, Poland
Centrum Onkologii im. Marii Skodowskiej-Curie
Warszawa , 02-78, Poland
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
Warszawa , 04-74, Poland
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
Wrocław , 50-55, Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
Wrocław , 51-12, Poland
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
Łódź , 90-54, Poland

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

812

Study ID:

NCT00598806

Recruitment Status:

Completed

Sponsor:


Spectrum Pharmaceuticals, Inc

How clear is this clinincal trial information?

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