Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
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: 802.0
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 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?