Bladder Cancer Clinical Trial
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Summary
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.
Full Description
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.
A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).
If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization [WHO]/International Society of Urologic Pathology [ISUP] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade [WHO/ISUP classification]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
All patients were to be followed for 2 years.
Eligibility 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 Apaziquone?
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, 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 10^9/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 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?
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There are 71 Locations for this study
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85032, United States
Sun City Arizona, 85032, United States
Burbank California, 91505, United States
Fresno California, 93720, United States
Laguna Woods California, 92653, United States
Los Angeles California, 90027, United States
Orange California, 92868, United States
San Bernardino California, 92404, United States
San Francisco California, 94121, United States
Denver Colorado, 80211, United States
Middlebury Connecticut, 06762, United States
Washington District of Columbia, 20006, United States
Lakeland Florida, 33805, United States
Longwood Florida, 32750, United States
Miami Florida, 33136, United States
New Port Richey Florida, 34652, United States
New Port Richey Florida, 34655, United States
Ocala Florida, 34474, United States
Sarasota Florida, 34237, United States
Tallahassee Florida, 32308, United States
Gainesville Georgia, 30501, United States
Macon Georgia, 31217, United States
Coeur d'Alene Idaho, 83814, United States
Meridian Idaho, 83642, United States
Chicago Illinois, 60637, United States
Mattoon Illinois, 61938, United States
Peoria Illinois, 61614, United States
Fort Wayne Indiana, 46825, United States
Jeffersonville Indiana, 47130, United States
Overland Park Kansas, 66211, United States
Shreveport Louisiana, 71106, United States
Annapolis Maryland, 21401, United States
Greenbelt Maryland, 20770, United States
Grand Rapids Michigan, 49546, United States
Saint Joseph Michigan, 49085, United States
Troy Michigan, 48084, United States
Missoula Montana, 59802, United States
Brick New Jersey, 08724, United States
Lawrenceville New Jersey, 08648, United States
Marlton New Jersey, 08053, United States
Sewell New Jersey, 08080, United States
Voorhees New Jersey, 08043, United States
Westampton New Jersey, 08060, United States
Albuquerque New Mexico, 87109, United States
Albany New York, 12208, United States
Albany New York, 12208, United States
Carmel New York, 10512, United States
Garden City New York, 11530, United States
Garden City New York, 11530, United States
Kingston New York, 12401, United States
New York New York, 10016, United States
Oneida New York, 13421, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14618, United States
Williamsville New York, 14221, United States
Cincinnati Ohio, 45212, United States
Columbus Ohio, 43220, United States
Springfield Oregon, 97477, United States
Bala-Cynwyd Pennsylvania, 19026, United States
Lancaster Pennsylvania, 17604, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Williamsport Pennsylvania, 17701, United States
Myrtle Beach South Carolina, 29572, United States
Germantown Tennessee, 38138, United States
Corpus Christi Texas, 78404, United States
Dallas Texas, 75231, United States
San Antonio Texas, 78229, United States
Fredericksburg Virginia, 22401, United States
Norfolk Virginia, 23502, United States
Virginia Beach Virginia, 23454, United States
Mountlake Terrace Washington, 98043, United States
Seattle Washington, 98104, United States
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