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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

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


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.


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?

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Shanta Chawla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Spectrum Pharmaceuticals, Inc

Authority:

United States: Food and Drug Administration

Study ID:

SPI-612

NCT ID:

NCT00598806

Start Date:

September 2007

Completion Date:

March 2012

Related Keywords:

  • Bladder Cancer
  • Noninvasive Bladder Cancer
  • Urinary Bladder Neoplasms

Name

Location

William Beaumont HospitalRoyal Oak, Michigan  48073
Medical & Clinical Research Associates, LLCBay Shore, New York  11706
Center for Urologic CareWest Reading, Pennsylvania  19611
Salt Lake ResearchSalt Lake City, Utah  84124
Advanced Urology Medical Center Clinical TrialsAnaheim, California  92801
Urology EnterprisesMarietta, Georgia  30060
North Fulton UrologyRoswell, Georgia  30076
Hines VA HospitalHines, Illinois  60141
Urology Associates of South TexasMcAllen, Texas  78503
Chesapeake Urology Research AssociatesTowson, Maryland  21204
Hal J. Bashein, D.O.West Palm Beach, Florida  33407
The Urology CenterSlidell, Louisiana  70458
PharmaTrials, Inc. - Male & Female UrologyHillsborough, New Jersey  08844
PharmaTrials, Inc.Hillsborough, New Jersey  08844
Urology Associates, PCManhasset, New York  11030
North Shore - LIJ Health System - The Arthur Smith Institute for UrologyNew Hyde Park, New York  11040
Alliance Urology SpecialistsGreensboro, North Carolina  27403
Piedmont Medical ResearchWinston-Salem, North Carolina  27103
Medical University of South Carolina, Dept. of UrologyCharleston, South Carolina  29425
Adult and Pediatric UrologistsAlexandria, Virginia  22304