Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant for Noninvasive Bladder Cancer
Summary
This is a multicenter, randomized, placebo-controlled, double-blind, study. Following TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® (Apaziquone) or matching placebo instilled within 6 hours of surgery. Patients will be seen for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence and progression. If the histology of the patient's tumor is other than Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive further treatment in accordance with current treatment guidelines, following which the patient will be followed up cystoscopically every three months through year two for tumor recurrence and progression.
The primary endpoint is to evaluate the recurrence rate at 2 years in randomized patients with tumor histology Ta, G1-G2 who receive TUR-BT plus EOquin® versus those who receive TUR-BT plus placebo.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Bladder Cancer
Intervention
EOquin® (Apaziquone)
Location
Advanced Urology Medical Center Clinical Trials
Anaheim
California
United States
92801
Status
Active, not recruiting
Source
Spectrum Pharmaceuticals, Inc
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00598806
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Urinary Bladder Neoplasms
Tumors or cancer of the URINARY BLADDER.
Cystocele
A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.
Urinary Incontinence, Stress
Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.
Urinary Bladder Fistula
An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.
Urinary Bladder Neck Obstruction
Blocked urine flow through the bladder neck, the narrow internal urethral opening at the base of the URINARY BLADDER. Narrowing or strictures of the URETHRA can be congenital or acquired. It is often observed in males with enlarged PROSTATE glands.
Clinical Trials
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Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
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Markers of Response to Intravesical Bladder Cancer Therapy
The goal of this laboratory research study is to see if researchers can predict whose cancer will stay in remission and whose will return in patients receiving treatment for bladder cancer
Quality of Life in Patients With Bladder Cancer
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PubMed Articles
Due to the high incidence and recurrence rate non-muscle invasive bladder cancer (NMIBC) has a relevant impact. Raman spectroscopy and optical coherence tomography represent innovative diagnostic tool...
To confirm a microarray study that suggested that Kindlin-2 might play a role in the development and progression of bladder cancer. There has been no previous examination of Kindlin-2 expression in hu...
Bladder Polypoid Cystitis-Derived A20 Associates with Tumorigenesis.
Bladder chronic inflammation is associated with the pathogenesis of bladder cancer; the underlying mechanism is unclear. The PT53 gene is an important anticancer gene in the body, which is suppressed...
Synthesis and evaluation of a radioiodinated bladder cancer specific peptide.
Bladder cancer is the second most common cancer of the urinary tract, however the invasive cystoscopy is still the standard technique for diagnosis and surveillance of bladder cancer. Herein, we radio...
One of the principal objects of the scientific research network "German Bladder Cancer Network" is to consolidate research activities on bladder cancer. An overview about directions of current project...
