Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Drug: Placebo; Drug: Apaziquone; Procedure: TURBT

• Registration Number: NCT00598806
• Lead Sponsor: Spectrum Pharmaceuticals, Inc

Brief Summary

The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

Detailed Description

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.

A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).

* If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).

* If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).

All patients were to be followed for 2 years.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Disposition First Submitted: 2013-12-18
• Disposition First Submitted QC: 2015-05-26
• Disposition First Posted: 2015-06-19
• Results First Submitted: 2017-07-14
• Results First Submitted QC: 2017-07-14
• Results First Posted: 2017-08-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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, carcinoma in situ (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 TURBT 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?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apaziquone	TURBT	TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT
Placebo	Placebo	TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Placebo	TURBT	TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Apaziquone	Apaziquone	TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

Primary Outcome Measures

Name	Time	Method
Recurrence Rate at 2 Years	2 years	The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.

Secondary Outcome Measures

Name	Time	Method
Progression Rate at 2 Years	2 years	The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.
Time to Progression	2 years	The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.
Disease-Free Interval	2 years	The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause
Disease-Free Survival	2 years	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause
Number of Recurrences Per Patient	2 years	The number of histologically confirmed recurrences during the course of the study.
Overall Survival	2 years	The number of months from randomization to death from any cause.
Time to Recurrence	2 years	The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.

Trial Locations

Locations (76)

Advanced Urology Medical Center Clinical Trials; 🇺🇸 Anaheim, California, United States

Hal J. Bashein, D.O.; 🇺🇸 West Palm Beach, Florida, United States

Urology Enterprises; 🇺🇸 Marietta, Georgia, United States

North Fulton Urology; 🇺🇸 Roswell, Georgia, United States

Hines VA Hospital; 🇺🇸 Hines, Illinois, United States

The Urology Center; 🇺🇸 Slidell, Louisiana, United States

Chesapeake Urology Research Associates; 🇺🇸 Towson, Maryland, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

PharmaTrials, Inc. - Male & Female Urology; 🇺🇸 Hillsborough, New Jersey, United States

PharmaTrials, Inc.; 🇺🇸 Hillsborough, New Jersey, United States

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