single dose intravesical apaziquone postoperative in patients undergoing turbt for noninvasive bladder cancer (spi-611)

Conditions: Bladder Cancer

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.

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 \ 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?

Keywords: noninvasive bladder cancer