Status:
COMPLETED
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (TURB...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- (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
- (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?
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT00461591
Start Date
April 1 2007
End Date
January 1 2012
Last Update
March 30 2021
Active Locations (74)
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1
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
2
BCG Oncology
Phoenix, Arizona, United States, 85032
3
Sun Health Research Institute
Sun City, Arizona, United States, 85032
4
Urology Associates Medical Group
Burbank, California, United States, 91505