Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

Exclusion Criteria

• •1. Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?
• •2. Has the patient ever received apaziquone?
• •3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?
• •4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?
• •5. Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?
• •6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma?
• •7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma?
• •8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past?
• •9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years?
• •10. Does the patient have a bleeding disorder or a screening platelet count \< 50 x 109/L?
• •11. Does the patient have a screening hemoglobin \< 10 mg/dL?
• •12. Does the male patient have a serum PSA \> 10 ng/mL?
• •13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive?
• •14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study?
• •15. Has the patient participated in an investigational protocol within the past 90 days?
• •16. Is the patient pregnant or breast feeding?
• •17. Does the patient have a life expectancy of \<3 years?
• •18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except
• •* non-melanoma skin tumors
• •* stage 0 (in situ) cervical carcinoma
• •* undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer?
• •19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent?
• •20. Does the patient have tumor in a bladder diverticulum?
• •21. Does the patient have a known allergy to red color food dye?