A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial of Single-Dose Intravesical EOquinâ as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer

Conditions: The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor.
MedDRA version: 9.1Level: LLTClassification code 10005005Term: Bladder cancer recurrent
MedDRA version: 9.1Level: LLTClassification code 10005007Term: Bladder cancer stage 0, without cancer in situ
MedDRA version: 9.1Level: LLTClassification code 10005003Term: Bladder cancer

Registration Number: EUCTR2009-015404-26-PL

Lead Sponsor: Spectrum Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. The patient provides written informed consent. 2. Patient at least 18 years old. 3. Patient has 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 using an acceptable/effective method of contraception. 5. If the patient is a female of childbearing potential, she has had a negative serum pregnancy test within the past 14 days. 6. Patient willing and able to abide by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient may not have more than 4 bladder tumors. 2. Any single bladder tumor may not exceed 3.5 cm in diameter. 3. Patient must not have a single, primary bladder tumor <0.5 cm and have no previous diagnosis of bladder cancer. 4. Patient cannot have ever received EOquin®. 5. Patient cannot have, or ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification]). 6. Patient cannot have, or ever had any bladder tumor with histology other than transitional cell carcinoma. 7. Patient cannot have, or ever had, CIS. 8. Patient cannot have an active urinary tract infection. 9. Patient cannot have a bleeding disorder or a screening platelet count < 100 x 10 9/L. 10. Patient cannot have any unstable medical condition that would make it unsafe for him/her to undergo TUR-BT under general or spinal anesthesia. 11. Patient cannot have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L or a screening creatinine > 2 mg/dL. 12. Patient cannot have a known immunodeficiency disorder. 13. Patient cannot have received any investigational treatment within the past 30 days. 14. Patient cannot be breast feeding. 15. Patient cannot have a history of interstitial cystitis. 16. Patient cannot have a history of allergy to red color food dye. 17. Patient cannot have had transitional cell carcinoma of the bladder within the past 4 months.