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

Sponsor:	Spectrum Pharmaceuticals, Inc
Information provided by:	Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00598806

Purpose

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.

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

Drug Information available for: Apaziquone

U.S. FDA Resources

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 ]

Estimated Enrollment:	800
Study Start Date:	September 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: EOquin® (Apaziquone) 4mg in 40 mL for intravesical instillation
2: Experimental EOquin® (Apaziquone)	Drug: EOquin® (Apaziquone) 4mg in 40 mL for intravesical instillation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598806

Contacts

Contact: Shanta Chawla, MD	(949) 788-6700 ext 257	schawla@spectrumpharm.com
Contact: Deborah Robbins	(949) 788-6700 ext 235	drobbins@spectrumpharm.com

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Locations

United States, California
Advanced Urology Medical Center Clinical Trials	Recruiting
Anaheim, California, United States, 92801
Contact: Vera Martinez 714-776-2030
Principal Investigator: Alfred Sidhom, MD
United States, Florida
Hal J. Bashein, D.O.	Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Sara Fonseca 561-848-8700
Principal Investigator: Hal J Bashein, DO
United States, Georgia
Urology Enterprises	Recruiting
Marietta, Georgia, United States, 30060
Contact: Becky Hippensteel 678-594-0108
Principal Investigator: Ronald Roper, MD
North Fulton Urology	Recruiting
Roswell, Georgia, United States, 30076
Contact: Cindy Nelson, RN 770-752-8632
Principal Investigator: Lewis Kriteman, MD
United States, Illinois
Hines VA Hospital	Recruiting
Hines, Illinois, United States, 60141
Contact: Thomas P. Koppes, RN 708-202-8387 ext 21786
Principal Investigator: Jeff Branch, MD
United States, Louisiana
The Urology Center	Recruiting
Slidell, Louisiana, United States, 70458
Contact: Gala Daftary 985-649-6660
Principal Investigator: Mahmoud Daftary, MD
United States, Maryland
Chesapeake Urology Research Associates	Not yet recruiting
Towson, Maryland, United States, 21204
Contact: Debra Robertson 410-825-6310 ext 163
Principal Investigator: Ronald Tutrone, MD
Chesapeake Urology Research Associates	Not yet recruiting
Baltimore, Maryland, United States, 21237
Contact: Dorothy Richardson 410-803-0089
Contact: Janette Class, RN 410-391-6131
Principal Investigator: William Dowling, MD
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Deborah Hasenau 248-551-1225
Principal Investigator: Ronald Rubenstein, MD
United States, New Jersey
PharmaTrials, Inc. - Somerset Ambulatory Surgical Center	Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Malgorzata "Gosha" Stecko-Brzozowski, RN 908-359-2099
Principal Investigator: Joel M. Fischer, MD
PharmaTrials, Inc. - Male & Female Urology	Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Malgorzata "Gosha" Stecko-Brzozowski, RN 908-359-2099
Principal Investigator: Richard Maggio, MD
PharmaTrials, Inc.	Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Monika Tiemeyer, RN 908-359-2099
Principal Investigator: Anthony Catanese, MD
United States, New York
North Shore - LIJ Health System - The Arthur Smith Institute for Urology	Recruiting
New Hyde Park, New York, United States, 11040
Contact: Dolorita de Jesus 516-734-8515
Principal Investigator: Gary Weiss, MD
Urology Associates, PC	Recruiting
Manhasset, New York, United States, 11030
Contact: Tiffanie Pederson 516-320-7047
Principal Investigator: Christopher Johnson, MD
Medical & Clinical Research Associates, LLC	Recruiting
Bay Shore, New York, United States, 11706
Contact: Joann Hallgren, RN 631-665-3734
Principal Investigator: Daniel C. Kim, MD
United States, North Carolina
Piedmont Medical Research	Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Megan Fox 336-768-8062
Principal Investigator: David O. Cook, MD
Alliance Urology Specialists	Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Pattie Edwards 336-274-1114 ext 5328
Contact: Karen Michael, RN 336-274-1114 ext 5328
Principal Investigator: John J. Wrenn, MD
United States, Pennsylvania
Center for Urologic Care	Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Carol Wenger, RN 610-525-2515
Principal Investigator: Guy T. Bernstein, MD
United States, South Carolina
Medical University of South Carolina, Dept. of Urology	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jessica Jenkins 843-876-0630
Principal Investigator: Stephen Savage, MD
United States, Texas
Urology Associates of South Texas	Recruiting
McAllen, Texas, United States, 78503
Contact: Marissa Leal 956-429-0357
Principal Investigator: Henry E. Ruiz, MD
United States, Utah
Salt Lake Research	Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Rosa Vargas 801-288-9778
Principal Investigator: Stephen Richardson, MD
United States, Virginia
Adult and Pediatric Urologists	Recruiting
Alexandria, Virginia, United States, 22304
Contact: Pamela Harrison 703-370-2132
Principal Investigator: George Tawill, MD
Canada
Centre hospitalier universitaire de Quebec	Recruiting
Quebec, Canada, G1R3S3
Contact: Denyse L'Héreault 418-691-5050
Principal Investigator: Yves Fradet, MD
Canada, Alberta
Prostate Cancer Institute	Recruiting
Calgary, Alberta, Canada, T2V4R6
Contact: Madalyn Vachon, RN 403-301-2437
Principal Investigator: Jay Lee, MD
Canada, British Columbia
Lintor Medical, Inc.	Recruiting
North Vancouver, British Columbia, Canada, V7L2P7
Contact: Maureen McGrath 604-765-9287
Principal Investigator: Victor Chow, MD
G. Steinhoff Clinical Research	Recruiting
Victoria, British Columbia, Canada, V8V3N1
Contact: Catherine Douglas 250-388-0840
Principal Investigator: Gary Steinhoff, MD
Andreou Research	Recruiting
Surrey, British Columbia, Canada, V3V1N1
Contact: Wendy Largy 604-583-2271
Principal Investigator: Cal Andreou, MD
Southern Interior Medical Research Corporation	Recruiting
Kelowna, British Columbia, Canada, V1Y2H4
Contact: Joe Husch 250-764-1949
Principal Investigator: Thomas J. Kinhan, MD
Can-Med Clinical Research, Inc	Recruiting
Victoria, British Columbia, Canada, V8T5G1
Contact: Renza Brown 250-370-2606
Principal Investigator: Peter Pommerville, MD
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H2Y9
Contact: Susan Winch 902-473-6604
Principal Investigator: Ricardo A. Rendon, MD
Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Irene McNeal 416-480-6100 ext 2431
Principal Investigator: Laurence Klotz, MD
Urotec	Recruiting
Oshawa, Ontario, Canada, L1H7K4
Contact: Connie Martinell 905-721-4300 ext 5353
Principal Investigator: Arun Mathur, MD
Brantford Urology Research	Recruiting
Brantford, Ontario, Canada, N3R4N3
Contact: Nora Leung 519-753-9221
Principal Investigator: Wilson Leung, MD
The Male/Female Health and Research Center - Royal Court Medical Centre	Recruiting
Barrie, Ontario, Canada, L4M7G1
Contact: Karen Hill 705-727-0551
Contact: Judy Cannon 705-739-7016
Principal Investigator: Joseph Zadra, MD
London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A5W9
Contact: Wendy Shoff, RN 519-685-8500 ext 57350
Contact: Catherine Hildebrand 519-685-8500 ext 53535
Principal Investigator: Joseph Chin, MD
Saint Joseph Health Center	Recruiting
Toronto, Ontario, Canada, M6S4W4
Contact: Kusum Sharma 416-767-0995
Principal Investigator: Umesh Jain, MD
Urology Resource Centre	Recruiting
Burlington, Ontario, Canada, L7S1V2
Contact: Jane Love 905-681-9300
Principal Investigator: William Love, MD
University Health Network Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Kelly Caetano 416-946-4501 ext 3141
Principal Investigator: Neil Fleshner, MD
Dr. Bernard Goldfarb	Recruiting
North Bay, Ontario, Canada, P1B7K8
Contact: Terri Moreau 705-482-1063
Principal Investigator: Bernard Goldfarb, MD
The Fe/Male Health Centre	Recruiting
Oakville, Ontario, Canada, L6H3P1
Contact: Djordje Adanja 905-338-3130 ext 225
Contact: Rupi Dhaliwal 905-338-3130 ext 226
Principal Investigator: Richard Casey, MD
The Ottawa Hospital - Civic	Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: Peggy Graham 613-798-5555 ext 17594
Principal Investigator: Christopher Morash, MD
Mor Urology, Inc.	Recruiting
Newmarket, Ontario, Canada, L3X1W1
Contact: Diane Stone 905-853-7468
Contact: Donna Liquornik 905-853-7468
Principal Investigator: Morrie Liquornik, MD
AGT Research	Recruiting
Scarborough, Ontario, Canada, M1P2T7
Contact: Beverley Taylor 416-439-8913
Principal Investigator: Allan Toguri, MD
Urology & Male Infertility	Recruiting
Scarborough, Ontario, Canada, M1S4V5
Contact: Polina Schvarts 416-754-1019
Principal Investigator: Allan Abramovitch, MD
Urology Associates, Urologic Medical Research	Recruiting
Kitchener, Ontario, Canada, N2N2B9
Contact: Linda Morriss 519-578-0470 ext 3
Principal Investigator: Russell B. Egerdie, MD
Kingston General Hospital / Queen's University	Recruiting
Kingston, Ontario, Canada, K7L3J7
Contact: Laurel Emerson 613-548-6033
Principal Investigator: Robert D. Siemens, MD
Toronto East General Hospital	Recruiting
Toronto, Ontario, Canada, M4C5T2
Contact: Sandra Brazel 416-233-7231
Principal Investigator: Rajiv K. Singal, MD
Mahoney Medicine Professional Corporation	Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Tammy Knight 613-737-8659
Principal Investigator: John Mahoney, MD
The Male Health Centre	Recruiting
Toronto, Ontario, Canada, M6A3B5
Contact: Shelley Burton 416-256-9606
Principal Investigator: Jack Barkin, MD
Orillia Urology Associates	Recruiting
Orillia, Ontario, Canada, L3V7V1
Contact: Kurt Fountain 705-325-8004
Principal Investigator: Ben Okafo, MD
Stanley Flax Medical Professional Corporation	Recruiting
North York, Ontario, Canada, M3B3S6
Contact: Tracy Hobbins 416-449-8551
Principal Investigator: Stanley Flax, MD
G. Kenneth Jansz Medicine Professional Corporation	Recruiting
Burlington, Ontario, Canada, L7N3V2
Contact: Linda Hager 905-681-9149
Principal Investigator: Ken Jansz, MD
ADA Medical Ltd.	Recruiting
Peterborough, Ontario, Canada, K9J7B3
Contact: Michelle Thornley, RN 416-617-6338
Principal Investigator: Mohamed El Harram, MD
Canada, Quebec
UroLaval	Recruiting
Laval, Quebec, Canada, H7G2E6
Contact: Jane Bell 450-972-2474
Principal Investigator: Jean Simrad, MD
McGill Urology Associates	Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Wendella Hamilton 514-735-9981 ext 105
Principal Investigator: Wassim Kassouf, MD
Centre Hospitalier Universitaire de Sherbrooke	Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Contact: Elsie Morneau 819-346-1110 ext 12827
Principal Investigator: Michel Carmel, MD
Ultra-Med, Inc.	Recruiting
Pointe Clare, Quebec, Canada, H9R4S3
Contact: Sylvia Boudreau 514-426-8008
Principal Investigator: David Eiley, MD
Poland
Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie	Not yet recruiting
Warszawa, Poland, 04-749
Contact: Andrzej Borówka, Prof. dr hab. n. med. +48 022 815 68 61
Principal Investigator: Andrzej Borówka, Prof. dr hab. n. med.
Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń	Recruiting
Warszawa, Poland, 02-005
Contact: Andrzej Borkowski, Prof. dr hab. n. med. +48 022 502 21 48
Principal Investigator: Andrzej Borkowski, Prof. dr hab. n. med.
Centrum Onkologii im. Marii Skodowskiej-Curie	Not yet recruiting
Warszawa, Poland, 02-781
Contact: Tomasz Demkow, Prof. dr hab. n. med. +48 022 546 30 53
Principal Investigator: Tomasz Demkow, Prof. dr hab. n. med.
Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego	Not yet recruiting
Warszawa, Poland, 00-416
Contact: Wojciech Pypno, Dr hab. n. med. 48 022 621 71 78
Principal Investigator: Wojciech Pypno, Dr hab. n. med.
Szpital Specjalistyczny w Kościerzynie	Not yet recruiting
Kościerzyna, Poland, 83-400
Contact: Krzysztof Szkarłat, Dr n. med. +48 058 686 86 59
Principal Investigator: Krzysztof Szkarłat, Dr n. med.
Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie	Not yet recruiting
Pruszków, Poland, 05-800
Contact: Andrzej Stokłosa, Dr n. med. +48 022 825 44 38
Principal Investigator: Andrzej Stokłosa, Dr n. med.
Wojewódzki Szpital Specjalistyczny W Siedlcach	Not yet recruiting
Siedlce, Poland, 08-110
Contact: Tadeusz Dmowski, Dr n. med. 48 025 640 32 98
Principal Investigator: Tadeusz Dmowski, Dr n. med.
Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów	Not yet recruiting
Łódź, Poland, 90-549
Contact: Marek Sosnowski, Prof. dr hab. n. med. +48 042 636 82 14
Principal Investigator: Marek Sosnowski, Prof. dr hab. n. med.
Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach	Not yet recruiting
Pabianice, Poland, 95-200
Contact: Grzegorz Krzyżanowski, Dr n. med. +48 042 225 37 76
Principal Investigator: Grzegorz Krzyżanowski, Dr n. med.
Uniwersytecki Szpital Kliniczny	Not yet recruiting
Białystok, Poland, 15-276
Contact: Barbara Darewicz, Prof. dr hab. n. med.
Principal Investigator: Barbara Darewicz, Prof. dr hab. n. med.
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Not yet recruiting
Lublin, Poland, 20-954
Contact: Krzysztof Bar, Prof. dr hab. n. med.
Principal Investigator: Krzysztof Bar, Prof. dr hab. n. med.
Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej	Not yet recruiting
Kielce, Poland, 25-734
Contact: Piotr Chłosta, Dr n. med. +48 041 367 47 73
Principal Investigator: Piotr Chłosta, Dr n. med.
Niepubliczny Zakład Opieki Zdrowotnej "Racławicka"	Not yet recruiting
Kraków, Poland, 30-017
Contact: Marek Wyczółkowski, Dr hab. n. med. +48 012 646 82 49
Principal Investigator: Marek Wyczółkowski, Dr hab. n. med.
Szpital Miejski im. Prof. E. Michałowskiego	Not yet recruiting
Katowice, Poland, 40-073
Contact: Wiesław Duda, Dr n. med. +48 032 251 54 36
Principal Investigator: Wiesław Duda, Dr n. med.
Szpital Wojewódzki w Bielsku-Białej	Not yet recruiting
Bielsko-Biała, Poland, 43-316
Contact: Krzysztof Pliszek, Dr n. med. +48 033 810 23 54
Principal Investigator: Krzysztof Pliszek, Dr n. med.
Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3	Recruiting
Rybnik, Poland, 44-200
Contact: Jacek Węglorz, Dr n. med. +48 032 429 15 79
Principal Investigator: Jacek Węglorz, Dr n. med.
Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu	Not yet recruiting
Wrocław, Poland, 50-556
Contact: Romuald Zdrojowy, Prof. dr hab. n. med. +48 071 359 21 61
Principal Investigator: Romuald Zdrojowy, Prof. dr hab. n. med.
Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy	Not yet recruiting
Wrocław, Poland, 51-124
Contact: Jerzy Sokołowski, Dr n. med. +48 071 327 03 15
Principal Investigator: Jerzy Sokołowski, Dr n. med.
Zakład Opieki Zdrowotnej Poznań - Stare Miasto	Not yet recruiting
Poznań, Poland, 61-285
Contact: Paweł Kalwas, Dr n. med. +48 061 873 92 37
Principal Investigator: Paweł Kalwas, Dr n. med.
Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu	Not yet recruiting
Inowrocław, Poland, 88-100
Contact: Szymon Kwiatkowski, Dr n. med. +48 052 354 55 68
Principal Investigator: Szymon Kwiatkowski, Dr n. med.
Pomorska Akademia Medyczna	Not yet recruiting
Szczecin, Poland, 70-111
Contact: Andrzej Sikorski, Prof. dr hab. n. med. +48 091 466 11 00
Principal Investigator: Andrzej Sikorski, Prof. dr hab. n. med.
Wojewódzki Szpital Specjalistyczny im Janusza Korczaka	Not yet recruiting
Słupsk, Poland, 76-200
Contact: Jacek Ołubiec, Dr n. med. +48 059 841 34 15
Principal Investigator: Jacek Ołubiec, Dr n. med.
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku	Not yet recruiting
Gdańsk, Poland, 80-402
Contact: Kazimierz Krajka, Prof. dr hab. n. med. +48 058 349 38 24
Principal Investigator: Kazimierz Krajka, Prof. dr hab. n. med.
Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON	Not yet recruiting
Warszawa, Poland, 00-909
Contact: Henryk Zieliński, Dr hab. n. med. +48 022 681 63 19
Principal Investigator: Henryk Zieliński, Dr hab. n. med.

Sponsors and Collaborators

Spectrum Pharmaceuticals, Inc

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

Responsible Party:	Spectrum Pharmaceuticals ( Spectrum Pharmaceuticals )
Study ID Numbers:	SPI-612
Study First Received:	January 11, 2008
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00598806 History of Changes
Health Authority:	United States: Food and Drug Administration