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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Apaziquone

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?