Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing TUR-BT

Condition(s) targeted: Bladder Cancer

Intervention: EOquin® (Apaziquone) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Spectrum Pharmaceuticals, Inc

Official(s) and/or principal investigator(s):
Mark Soloway, MD, Principal Investigator, Affiliation: University of Miami

Overall contact:
Shanta Chawla, MD, Phone: (949) 788-6700, Ext: 257, Email: schawla@spectrumpharm.com

The purpose of this study is to evaluate the recurrence rate of noninvasive bladder cancer at 2 years in patients with tumor histology Ta, G1-G2 who are randomized to receive TUR-BT plus EOquin® versus those who are randomized to receive TUR-BT plus placebo.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Recurrence Rate at 2 years

Secondary outcome:

Time to Recurrence

Progression to Higher Stage or Grade

Number of Recurrences per Patient

Disease Free Interval

Disease Free Survival

Overall Survival

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® 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: (All questions must be answered YES)

- 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 stage 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 questions must be answered NO)

- Does the patient have more than 4 bladder tumors?

- Does any single bladder tumor exceed 3. 5 cm in diameter?

- Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor

<0. 5 cm?

- 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 stage 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, CIS?

- Does the patient have an active urinary tract infection?

- Does the patient have a bleeding disorder or a screening platelet count < 100 x

10^9/L?

- 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?

- Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute

neutrophil count < 1. 5 x 10^9/L or a screening creatinine > 2 mg/dL?

- 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?

Shanta Chawla, MD, Phone: (949) 788-6700, Ext: 257, Email: schawla@spectrumpharm.com

BCG Oncology, Phoenix, Arizona 85032, United States; Recruiting
Kay Johnson, Phone: 602-493-6626
Don Lamm, MD, Principal Investigator

Sun Health Research Institute, Sun City, Arizona 85351, United States; Recruiting
Carolyn Liebsack, Phone: 623-875-6514
Jeffery Stern, MD, MPH, Principal Investigator

South Orange County Medical Research Center, Laguna Woods, California 92653, United States; Recruiting
Christy Leach, RN, Phone: 949-499-2279
Jay Young, MD, Principal Investigator

The Urology Center of Colorado, Denver, Colorado 80211, United States; Recruiting
Sarah Koceja, Phone: 303-421-5783
Lawrence Karsh, MD, Principal Investigator

Connecticut Clinical Research Center, Middlebury, Connecticut 06762, United States; Recruiting
Brendaliz Konopka, Phone: 203-757-2296
Robert Feldman, MD, Principal Investigator

Florida Foundation for Healthcare Research, Ocala, Florida 34474, United States; Recruiting
Joanne Grover, Phone: 352-237-3949
Ira Klimberg, MD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Dinorah Rodriguez, Phone: 305-243-7207
Mark Soloway, MD, Principal Investigator

Advanced Research Institute, New Port Richey, Florida 34652, United States; Recruiting
Gabrielle Handerson, Phone: 727-835-3261
Juan Otheguy, MD, Principal Investigator

Southeastern Research Group, Inc., Tallahassee, Florida 32308, United States; Recruiting
Mary Anne Taylor, Phone: 850-201-0411
J. Daniel Rackley, MD, Principal Investigator

Tampa Bay Urology Research, Tampa, Florida 33607, United States; Recruiting
Linda Seibert, Phone: 813-872-7881
Tod Fusia, MD, Principal Investigator

Urology Consultants, Longwood, Florida 32750, United States; Recruiting
Stacey Kinsey, Phone: 407-332-0777
Steven Brooks, MD, Principal Investigator

Florida Urology Specialists, Sarasota, Florida 34237, United States; Recruiting
Shannon Lynch, Phone: 941-309-7000, Ext: 7116
Thomas Williams, MD, Principal Investigator

Idaho Urologic Institute, P.A., Meridian, Idaho 83642, United States; Recruiting
Katie Gries, Phone: 208-639-4938
Stephen Miller, MD, Principal Investigator

Speciality Care Research, Peoria, Illinois 61614, United States; Recruiting
Jackie Schultz, Phone: 309-683-1125
Giovanni Colombo, MD, Principal Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Josephine Silvestre, Phone: 773-702-3080
Gary Steinberg, MD, Principal Investigator

Northeast Indiana Research, LLC, Ft. Wayne, Indiana 46825, United States; Recruiting
Mary Hageman, RN, Phone: 260-434-1939
Christopher Steidle, MD, Principal Investigator

Metropolitan Urology, Jeffersonville, Indiana 47130, United States; Recruiting
Debbie Johnson, Phone: 812-288-2611
James Bailen, MD, Principal Investigator

Kansas City Urology Care, P.A., Overland Park, Kansas 66211, United States; Recruiting
John Beuscher, Phone: 913-647-4173, Email: jbeuscher@kcurology.com
Steven Nash, MD, Principal Investigator

Dr's. Werner, Murdock & Francis, PA, Urology Associates, Greenbelt, Maryland 20770, United States; Recruiting
Lisa Drezer, MD, Phone: 301-441-8900, Ext: 114
Myron Murdock, MD, Principal Investigator

Anne Arundel Urology, Annapolis, Maryland 21401, United States; Recruiting
Elizabeth D'Antonio, Phone: 410-266-8049, Ext: 143
Eric Schwartz, MD, Principal Investigator

Five Valleys Urology, Missoula, Montana 59303, United States; Recruiting
Jennifer Hays, Phone: 406-329-2864
Karl Westenfelder, MD, Principal Investigator

Delaware Valley Urology, LLC-Westampton, Westampton, New Jersey 08060, United States; Recruiting
Rene Haney, Phone: 609-914-0021, Ext: 125
Robert Goldlust, MD, Principal Investigator

Lawrenceville Urologist, Lawrenceville, New Jersey 08648, United States; Recruiting
Julie Prettyman, Phone: 609-895-1991
Gary Karlin, MD, Principal Investigator

Delaware Valley Urology, LLC - Voorhees, Voorhees, New Jersey 08043, United States; Recruiting
Catherine Kavalchick, Phone: 856-751-5288
Louis Keeler, MD, Principal Investigator

Deleware Valley Urology, LLC-Washington Township, Sewell, New Jersey 08080, United States; Recruiting
Michelle Redman, Phone: 856-218-3025
Robert Barsky, DO, Principal Investigator

Delaware Valley Urology, LLC-Marlton, Marlton, New Jersey 08053, United States; Recruiting
Diane Horner, Phone: 856-985-4286
Charles Orth, Jr., MD, Principal Investigator

Urology Group of New Mexico, Albuquerque, New Mexico 87109, United States; Recruiting
Mary Lou Jones, Phone: 505-872-4090, Ext: 118
Frederick Snoy, MD, Principal Investigator

Hudson Valley Urology, Poughkeepsie, New York 12601, United States; Recruiting
Alexa Harrington, Phone: 845-458-8730
Evan Goldfischer, MD, Principal Investigator

University Urology Associates, New York, New York 10016, United States; Recruiting
Betsy Ortiz, Phone: 212-686-9015, Ext: 9
Jed Kaminetsky, MD, Principal Investigator

Urological Surgeons of Long Island, P.C., Garden City, New York 11530, United States; Recruiting
Vincent Gandolfo, Phone: 516-742-3200
Robert Edelman, MD, Principal Investigator

Urology Associates of Rochester, LLC, Rochester, New York 14618, United States; Recruiting
Eileen Stone, Phone: 585-232-2980
David Dever, MD, Principal Investigator

Accumed Research Associates, Garden City, New York 11530, United States; Recruiting
Kerri Weingard, Phone: 516-746-2190
Mitchell Efros, MD, Principal Investigator

Hudson Valley Urology, PC, Kingston, New York 12401, United States; Recruiting
Jeanie Hefele, Phone: 845-339-4900, Ext: 110
Jose Sotolongo, MD, Principal Investigator

Oneida Health Care Center, Oneida, New York 13421, United States; Recruiting
Tracy Griffith, Phone: 315-363-8862
Bashar Omarbasha, MD, Principal Investigator

TriState Urologic Services PSC, Inc., Cincinnati, Ohio 45212, United States; Recruiting
Vicki Rice, Phone: 513-366-3412
Bernard L Hertzman, MD, Principal Investigator

University Urologists of Cleveland, Inc., Cleveland, Ohio 44106, United States; Recruiting
Claudia Lillibridge, Phone: 216-844-8205
Edward Cherullo, MD, Principal Investigator

Oregon Urology Institute, Springfield, Oregon 97477, United States; Recruiting
Janice Bebee, Phone: 541-284-5508
Peter Bergreen, MD, Principal Investigator

Urologic Consultants of South Eastern Pennsylvania, Bala Cynwyd, Pennsylvania 19026, United States; Recruiting
Cheryl Zinar, Phone: 610-667-0458
Lawrence Belkoff, MD, Principal Investigator

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States; Recruiting
Christine Jerome, Phone: 215-728-3853
Richard Greenberg, MD, Principal Investigator

Urological Associates of Lancaster, Lancaster, Pennsylvania 17604, United States; Recruiting
Dorie Rodriguez, Phone: 717-431-2285
Paul Seiber, MD, Principal Investigator

Triangle Urology Group, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Chantall Mitchell, Phone: 412-281-1757
John Lyne, MD, Principal Investigator

Susquehenna Urology, Williamsport, Pennsylvania 17701, United States; Not yet recruiting
Debrah Scott, Phone: 570-326-8040
Steven Rockoff, MD, Principal Investigator

Grand Strand Urology, Myrtle Beach, South Carolina 29572, United States; Recruiting
Lori Gormanns, Phone: 843-449-1010, Ext: 251
Neil Shore, MD, Principal Investigator

The Conrad Pearson Clinic, Germantown, Tennessee 38138, United States; Recruiting
Kathleen Meier, Phone: 901-252-3402
Lynn Conrad, MD, Principal Investigator

Urology San Antonio Research, San Antonio, Texas 78229, United States; Recruiting
Beatrice Escamilla, Phone: 210-617-4116
Daniel Saltzstein, MD, Principal Investigator

Urology Clinics of North Texas, Dallas, Texas 75231, United States; Recruiting
Nicolette Ruiz, Phone: 214-691-1902
James Cochran, MD, Principal Investigator

Corpus Christi Urology Group LLC, Corpus Christi, Texas 78404, United States; Recruiting
Christi Grunberg, Phone: 361-884-6381
Robert Naismith, MD, Principal Investigator

Urology of Virginia, PC, Virginia Beach, Virginia 23454, United States; Recruiting
Laurie Jackson, Phone: 757-457-5462
Kim Ramsey, Phone: 757-457-5462

Urology of Virginia, PC, Norfolk, Virginia 23502, United States; Recruiting
Jennifer Kucenski, Phone: 757-457-5166
Robert Given, MD, Principal Investigator

Integrity Medical Research, LLC, Mountlake Terrace, Washington 98043, United States; Recruiting
Cherrie Sia, Phone: 425-275-0680
Karny Jacoby, MD, Principal Investigator

Starting date: April 2007
Ending date: October 2010
Last updated: February 4, 2008