Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant for Noninvasive Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00598806
First received: January 11, 2008
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

The primary endpoint is to evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.


Condition Intervention Phase
Bladder Cancer
Drug: EOquin® (Apaziquone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • To evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate time to first recurrence in patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate progression to higher stage or grade, number of recurrences per patient, disease free interval, disease free survival and overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To assess the safety of EOquin instilled into the bladder in the early postoperative period. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 813
Study Start Date: September 2007
Study Completion Date: March 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: EOquin® (Apaziquone)
4mg in 40 mL for intravesical instillation
Other Name: EOquin®
Experimental: 2
EOquin® (Apaziquone)
Drug: EOquin® (Apaziquone)
4mg in 40 mL for intravesical instillation
Other Name: EOquin®

Detailed Description:

This is a multicenter, randomized, placebo-controlled, double-blind, study. Following TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® (Apaziquone) or matching placebo instilled within 6 hours of surgery. Patients will be seen for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence and progression. If the histology of the patient's tumor is other than Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive further treatment in accordance with current treatment guidelines, following which the patient will be followed up cystoscopically every three months through year two for tumor recurrence and progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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 TUR-BT 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?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598806

  Hide Study Locations
Locations
United States, California
Advanced Urology Medical Center Clinical Trials
Anaheim, California, United States, 92801
United States, Florida
Hal J. Bashein, D.O.
West Palm Beach, Florida, United States, 33407
United States, Georgia
Urology Enterprises
Marietta, Georgia, United States, 30060
North Fulton Urology
Roswell, Georgia, United States, 30076
United States, Illinois
Hines VA Hospital
Hines, Illinois, United States, 60141
United States, Louisiana
The Urology Center
Slidell, Louisiana, United States, 70458
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
PharmaTrials, Inc. - Male & Female Urology
Hillsborough, New Jersey, United States, 08844
PharmaTrials, Inc.
Hillsborough, New Jersey, United States, 08844
United States, New York
Medical & Clinical Research Associates, LLC
Bay Shore, New York, United States, 11706
Urology Associates, PC
Manhasset, New York, United States, 11030
North Shore - LIJ Health System - The Arthur Smith Institute for Urology
New Hyde Park, New York, United States, 11040
United States, North Carolina
Alliance Urology Specialists
Greensboro, North Carolina, United States, 27403
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
Medical University of South Carolina, Dept. of Urology
Charleston, South Carolina, United States, 29425
United States, Texas
Urology Associates of South Texas
McAllen, Texas, United States, 78503
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Adult and Pediatric Urologists
Alexandria, Virginia, United States, 22304
Canada, Alberta
Prostate Cancer Institute
Calgary, Alberta, Canada, T2V4R6
Canada, British Columbia
Lintor Medical, Inc.
North Vancouver, British Columbia, Canada, V7L2P7
Andreou Research
Surrey, British Columbia, Canada, V3V1N1
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V3N1
Can-Med Clinical Research, Inc
Victoria, British Columbia, Canada, V8T5G1
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
The Male/Female Health and Research Center - Royal Court Medical Centre
Barrie, Ontario, Canada, L4M7G1
Brantford Urology Research
Brantford, Ontario, Canada, N3R4N3
Urology Resource Centre
Burlington, Ontario, Canada, L7S1V2
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, Canada, L7N3V2
Kingston General Hospital / Queen's University
Kingston, Ontario, Canada, K7L3J7
Urology Associates, Urologic Medical Research
Kitchener, Ontario, Canada, N2N2B9
London Health Sciences Centre
London, Ontario, Canada, N6A5W9
Mor Urology, Inc.
Newmarket, Ontario, Canada, L3X1W1
Dr. Bernard Goldfarb
North Bay, Ontario, Canada, P1B7K8
Stanley Flax Medical Professional Corporation
North York, Ontario, Canada, M3B3S6
The Fe/Male Health Centre
Oakville, Ontario, Canada, L6H3P1
Orillia Urology Associates
Orillia, Ontario, Canada, L3V7V1
Urotec
Oshawa, Ontario, Canada, L1H7K4
ADA Medical Ltd.
Peterborough, Ontario, Canada, K9J7B3
AGT Research
Scarborough, Ontario, Canada, M1P2T7
Urology & Male Infertility
Scarborough, Ontario, Canada, M1S4V5
Saint Joseph Health Center
Toronto, Ontario, Canada, M6S4W4
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
The Male Health Centre
Toronto, Ontario, Canada, M6A3B5
Toronto East General Hospital
Toronto, Ontario, Canada, M4C5T2
Canada, Quebec
UroLaval
Laval, Quebec, Canada, H7G2E6
McGill Urology Associates
Montreal, Quebec, Canada, H3G1A4
Ultra-Med, Inc.
Pointe Clare, Quebec, Canada, H9R4S3
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Canada
Centre hospitalier universitaire de Quebec
Quebec, Canada, G1R3S3
Poland
Uniwersytecki Szpital Kliniczny
Białystok, Poland, 15-276
Szpital Wojewódzki w Bielsku-Białej
Bielsko-Biała, Poland, 43-316
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
Gdańsk, Poland, 80-402
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu
Inowrocław, Poland, 88-100
Szpital Miejski im. Prof. E. Michałowskiego
Katowice, Poland, 40-073
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce, Poland, 25-734
Szpital Specjalistyczny w Kościerzynie
Kościerzyna, Poland, 83-400
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"
Kraków, Poland, 30-017
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland, 20-954
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach
Pabianice, Poland, 95-200
Zakład Opieki Zdrowotnej Poznań - Stare Miasto
Poznań, Poland, 61-285
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie
Pruszków, Poland, 05-800
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3
Rybnik, Poland, 44-200
Wojewódzki Szpital Specjalistyczny W Siedlcach
Siedlce, Poland, 08-110
Pomorska Akademia Medyczna
Szczecin, Poland, 70-111
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, Poland, 76-200
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie
Warszawa, Poland, 04-749
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń
Warszawa, Poland, 02-005
Centrum Onkologii im. Marii Skodowskiej-Curie
Warszawa, Poland, 02-781
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
Warszawa, Poland, 00-416
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
Warszawa, Poland, 00-909
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu
Wrocław, Poland, 50-556
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy
Wrocław, Poland, 51-124
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów
Łódź, Poland, 90-549
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00598806     History of Changes
Other Study ID Numbers: SPI-612
Study First Received: January 11, 2008
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014