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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00598806

Run by

Spectrum Pharmaceuticals, Inc

People needed

812

Starts

2007-08-01

Expected to finish

2012-01-01

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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?

You may not qualify if…

• 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?

Where it is running

• Hal J. Bashein, D.O. — West Palm Beach, Florida, United States
• Urology Enterprises — Marietta, Georgia, United States
• North Fulton Urology — Roswell, Georgia, United States
• Hines VA Hospital — Hines, Illinois, United States
• The Urology Center — Slidell, Louisiana, United States
• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• PharmaTrials, Inc. - Male & Female Urology — Hillsborough, New Jersey, United States
• PharmaTrials, Inc. — Hillsborough, New Jersey, United States
• Medical & Clinical Research Associates, LLC — Bay Shore, New York, United States
• Urology Associates, PC — Manhasset, New York, United States
• North Shore - LIJ Health System - The Arthur Smith Institute for Urology — New Hyde Park, New York, United States
• Alliance Urology Specialists — Greensboro, North Carolina, United States
• Piedmont Medical Research — Winston-Salem, North Carolina, United States
• Center for Urologic Care — Bryn Mawr, Pennsylvania, United States
• Medical University of South Carolina, Dept. of Urology — Charleston, South Carolina, United States
• Urology Associates of South Texas — McAllen, Texas, United States
• Salt Lake Research — Salt Lake City, Utah, United States
• Adult and Pediatric Urologists — Alexandria, Virginia, United States
• Prostate Cancer Institute — Calgary, Alberta, Canada
• Lintor Medical, Inc. — North Vancouver, British Columbia, Canada
• Andreou Research — Surrey, British Columbia, Canada
• Can-Med Clinical Research, Inc — Victoria, British Columbia, Canada
• Advanced Urology Medical Center Clinical Trials — Anaheim, California, United States

Full record on ClinicalTrials.gov

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