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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
2 years
No
Shanta Chawla, MD
Principal Investigator
Spectrum Pharmaceuticals, Inc
United States: Food and Drug Administration
SPI-612
NCT00598806
September 2007
March 2012
Name | Location |
---|---|
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Medical & Clinical Research Associates, LLC | Bay Shore, New York 11706 |
Center for Urologic Care | West Reading, Pennsylvania 19611 |
Salt Lake Research | Salt Lake City, Utah 84124 |
Advanced Urology Medical Center Clinical Trials | Anaheim, California 92801 |
Urology Enterprises | Marietta, Georgia 30060 |
North Fulton Urology | Roswell, Georgia 30076 |
Hines VA Hospital | Hines, Illinois 60141 |
Urology Associates of South Texas | McAllen, Texas 78503 |
Chesapeake Urology Research Associates | Towson, Maryland 21204 |
Hal J. Bashein, D.O. | West Palm Beach, Florida 33407 |
The Urology Center | Slidell, Louisiana 70458 |
PharmaTrials, Inc. - Male & Female Urology | Hillsborough, New Jersey 08844 |
PharmaTrials, Inc. | Hillsborough, New Jersey 08844 |
Urology Associates, PC | Manhasset, New York 11030 |
North Shore - LIJ Health System - The Arthur Smith Institute for Urology | New Hyde Park, New York 11040 |
Alliance Urology Specialists | Greensboro, North Carolina 27403 |
Piedmont Medical Research | Winston-Salem, North Carolina 27103 |
Medical University of South Carolina, Dept. of Urology | Charleston, South Carolina 29425 |
Adult and Pediatric Urologists | Alexandria, Virginia 22304 |