Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
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.
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.
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?