Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Apaziquone; Placebo; TURBT
Intervention description: A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT; A single intravesical dose of placebo instilled into the bladder post-TURBT; TransUrethral Resection of the Bladder Tumor
Intervention MeSH terms: Apaziquone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 812.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Noninvasive 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.
    

Eligibility criteria:

        Inclusion Criteria:

        All of the following questions must be answered "Yes" in order for the patient to
        participate in the study.

          1. Has the patient given written informed consent?

          2. Is the patient at least 18 years old?

          3. Does the patient have transitional cell carcinoma of the bladder with clinically
             apparent tumor Ta, grade G1-G2?

          4. If the patient is a female of childbearing potential, is she using an
             acceptable/effective method of contraception?

          5. If the patient is a female of childbearing potential, has she had a negative serum
             pregnancy test within the past 14 days?

          6. Is the patient willing and able to abide by the protocol?

        Exclusion Criteria:

        All of the following questions must be answered "No" in order for the patient to
        participate in the study.

          1. Does the patient have more than 5 bladder tumors?

          2. Does any single bladder tumor exceed 3.5 cm in diameter?

          3. Does the patient have a single, primary bladder tumor <0.5 cm and has no previous
             diagnosis of bladder cancer?

          4. Has the patient ever received EOquin(r)?

          5. 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])?

          6. Does the patient have, or has the patient ever had any bladder tumor with histology
             other than transitional cell carcinoma?

          7. Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?

          8. Does the patient have an active urinary tract infection?

          9. Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L?

         10. Does the patient have any unstable medical condition that would make it unsafe for
             him/her to undergo TURBT under general or spinal anesthesia?

         11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil
             count < 1.5 x 109/L?

         12. Does the patient have a known immunodeficiency disorder?

         13. Has the patient received any investigational treatment within the past 30 days?

         14. Is the patient breast feeding?

         15. Does the patient have a history of interstitial cystitis?

         16. Does the patient have a history of allergy to red color food dye?

         17. Has the patient had transitional cell carcinoma of the bladder within the past 4
             months?