Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

NCT00461591 | Completed Phase 3 Results

• 1 other identifier: SPI-611
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 74

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.

Conditions

Bladder Cancer

Keywords

Noninvasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate at 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.

  2 years

Secondary Outcomes (7)

• Time to Recurrence

  2 years

• Progression Rate at 2 Years

  2 years

• Time to Progression

  2 years

• Number of Recurrences Per Patient

  2 years

• Disease Free Interval

  2 years

Study Arms (2)

Apaziquone

EXPERIMENTAL

TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

Drug: Apaziquone; Procedure: TURBT

Placebo

PLACEBO COMPARATOR

TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT

Drug: Placebo; Procedure: TURBT

Interventions

Apaziquone DRUG

A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT

Also known as: EOquin®, Qapzola

Apaziquone

Placebo DRUG

A single intravesical dose of placebo instilled into the bladder post-TURBT

Placebo

TURBT PROCEDURE

TransUrethral Resection of the Bladder Tumor

Apaziquone; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has the patient given written informed consent?
• Is the patient at least 18 years old?
• Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
• If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
• If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
• Is the patient willing and able to abide by the protocol?

You may not qualify if:

• Does the patient have more than 4 bladder tumors?
• Does any single bladder tumor exceed 3.5 cm in diameter?
• Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor \<0.5 cm?
• Has the patient ever received Apaziquone?
• Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade \[WHO/ISUP classification\])?
• Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
• Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
• Does the patient have an active urinary tract infection?
• Does the patient have a bleeding disorder or a screening platelet count \< 100 x 10\^9/L?
• Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
• Does the patient have a screening hemoglobin \< 10 mg/dL, a screening absolute neutrophil count \< 1.5 x 10\^9/L or a screening creatinine \> 2 mg/dL?
• Does the patient have a known immunodeficiency disorder?
• Has the patient received any investigational treatment within the past 30 days?
• Is the patient breast feeding?
• Does the patient have a history of interstitial cystitis?

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (74)

Alaska Clinical Research Center, LLC

Anchorage, Alaska, 99508, United States

Location

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

Sun Health Research Institute

Sun City, Arizona, 85032, United States

Location

Urology Associates Medical Group

Burbank, California, 91505, United States

Location

Urology Associates of Central CA

Fresno, California, 93720, United States

Location

South Orange County Medical Research Center

Laguna Woods, California, 92653, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Cancer Research Dept/St. Joseph Hospital

Orange, California, 92868, United States

Location

San Bernardino Urologic Association

San Bernardino, California, 92404, United States

Location

VA Medical Center

San Francisco, California, 94121, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Connecticut Clinical Research Center

Middlebury, Connecticut, 06762, United States

Location

Urologic Surgeons of Washington

Washington D.C., District of Columbia, 20006, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Urology Consultants

Longwood, Florida, 32750, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34652, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34655, United States

Location

Florida Foundation for Healthcare Research

Ocala, Florida, 34474, United States

Location

Florida Urology Specialists

Sarasota, Florida, 34237, United States

Location

Southeastern Research Group, Inc.

Tallahassee, Florida, 32308, United States

Location

Gainesville Urology, PC

Gainesville, Georgia, 30501, United States

Location

Urological Professional Association

Macon, Georgia, 31217, United States

Location

North Idaho Urology

Coeur d'Alene, Idaho, 83814, United States

Location

Idaho Urologic Institute, P.A.

Meridian, Idaho, 83642, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Urology Associates, SC

Mattoon, Illinois, 61938, United States

Location

Speciality Care Research

Peoria, Illinois, 61614, United States

Location

Northeast Indiana Research, LLC

Fort Wayne, Indiana, 46825, United States

Location

Metropolitan Urology

Jeffersonville, Indiana, 47130, United States

Location

Kansas City Urology Care, P.A.

Overland Park, Kansas, 66211, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Anne Arundel Urology

Annapolis, Maryland, 21401, United States

Location

Myron Murdock, MD, LLC

Greenbelt, Maryland, 20770, United States

Location

MMPC Urology

Grand Rapids, Michigan, 49546, United States

Location

Lakeside Urology, PC

Saint Joseph, Michigan, 49085, United States

Location

Michigan Institute of Urology, PC

Troy, Michigan, 48084, United States

Location

Five Valleys Urology

Missoula, Montana, 59802, United States

Location

Coastal Urological Associates, PA

Brick, New Jersey, 08724, United States

Location

AdvanceMed Research

Lawrenceville, New Jersey, 08648, United States

Location

Delaware Valley Urology, LLC-Marlton

Marlton, New Jersey, 08053, United States

Location

Deleware Valley Urology, LLC-Washington Township

Sewell, New Jersey, 08080, United States

Location

Delaware Valley Urology, LLC - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Delaware Valley Urology, LLC-Westampton

Woodlane, New Jersey, 08060, United States

Location

Urology Group of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Capital Region Urological Surgeons

Albany, New York, 12208, United States

Location

The Urological Institute of NE NY

Albany, New York, 12208, United States

Location

Adult and Pediatric Urology

Carmel, New York, 10512, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Urological Surgeons of Long Island, P.C.

Garden City, New York, 11530, United States

Location

Hudson Valley Urology, PC

Kingston, New York, 12401, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

CNY Urology, PC

Oneida, New York, 13421, United States

Location

Hudson Valley Urology

Poughkeepsie, New York, 12601, United States

Location

Urology Associates of Rochester, LLC

Rochester, New York, 14618, United States

Location

Center for Urologic Research of WNY, LLC

Williamsville, New York, 14221, United States

Location

TriState Urologic Services PSC, Inc.

Cincinnati, Ohio, 45212, United States

Location

Columbus Urology Research, LLC

Columbus, Ohio, 43220, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

Urologic Consultants of South Eastern Pennsylvania

Bala-Cynwyd, Pennsylvania, 19026, United States

Location

Urological Associates of Lancaster

Lancaster, Pennsylvania, 17604, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Triangle Urology Group

Pittsburgh, Pennsylvania, 15212, United States

Location

Susquehenna Urology

Williamsport, Pennsylvania, 17701, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

Location

Corpus Christi Urology Group LLC

Corpus Christi, Texas, 78404, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Mary Washington Hospital and Urology Associates of Fredericksburg

Fredericksburg, Virginia, 22401, United States

Location

Urology of Virginia, PC

Norfolk, Virginia, 23502, United States

Location

Urology of Virginia, PC

Virginia Beach, Virginia, 23454, United States

Location

Integrity Medical Research, LLC

Mountlake Terrace, Washington, 98043, United States

Location

Seattle Urological Associates

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

apaziquone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Gajanan Bhat, PhD
• Organization: Spectrum Pharmaceuticals

Gajanan.Bhat@sppirx.com

949-743-9219

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 30, 2021
• Results First Posted: August 15, 2017

Record last verified: 2021-03

Locations

US (74)