Alliance Urology Specialists

Protocol Number: SPI-612, Sponsor: Spectrum Pharmaceuticals

	Eligibility Criteria for participation: Male or Female 18 years of age or older Have been diagnosed with Ta, G1-G2 (low grade) transitional cell carcinoma of the bladder Have five or fewer tumors, none of which exceeds 3.5 cm in diameter. Cannot have a single, primary bladder tumor <0.5 cm and no previous diagnosis of bladder cancer Cannot have, or have ever had, any bladder tumor known to be other than Ta, G1-G2 (low grade) tumor Cannot have, or have ever had, CIS (carcinoma in situ) Cannot have been diagnosed with transitional cell carcinoma of the bladder within the past four months Cannot have, or have ever had any bladder tumor with histology other than transitional cell carcinoma No history of interstitial cystitis Overview of Study Appropriate patients will receive either placebo or EOquin® (Study Drug) instilled into the bladder within six hours of the end of the TUR procedure. Study Drug will be retained for 60 minutes, following which it will be drained from the bladder. If the histology of the patient’s tumor is confirmed Ta, G1-G2 (low grade ), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence. If the histology of the patient’s tumor is other than Ta, G1 or G2 (low grade), then the patient will be free to receive further treatment in accordance with current treatment guidelines, and will be followed up cystoscopically every three months through year two for tumor recurrence. Duration of Study All patients will be followed for two years. Clinical Research Coordinators: Patricia Edwards, RN (336) 274-1114 ext. 5322 Karen Michael, RN (336) 274-1114 ext. 5328 E-mail address: research@allianceurology.com

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