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Basic Trial Information
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. Eligibility Criteria Inclusion Criteria: All of the following questions must be answered "Yes" in order for the patient to participate in the study. 1. Has the patient given written informed consent? 2. Is the patient at least 18 years old? 3. Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2? 4. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 5. If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days? 6. Is the patient willing and able to abide by the protocol? Exclusion Criteria: All of the following questions must be answered "No" in order for the patient to participate in the study. 1. Does the patient have more than 5 bladder tumors? 2. Does any single bladder tumor exceed 3.5 cm in diameter? 3. Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer? 4. Has the patient ever received EOquin(r)? 5. Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification])? 6. Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have, or has the patient ever had, CIS? 8. Does the patient have an active urinary tract infection? 9. Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L? 10. Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TUR-BT under general or spinal anesthesia? 11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L? 12. Does the patient have a known immunodeficiency disorder? 13. Has the patient received any investigational treatment within the past 30 days? 14. Is the patient breast feeding? 15. Does the patient have a history of interstitial cystitis? 16. Does the patient have a history of allergy to red color food dye? 17. Has the patient had transitional cell carcinoma of the bladder within the past 4 months? Trial Lead Organizations/Sponsors Spectrum Pharmaceuticals, Incorporated
Trial Sites
Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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