Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
NCT ID: NCT00003725
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
1996-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.
Detailed Description
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OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone. Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes. Arm II: Patients undergo only surgery to remove bladder tumors. Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: This study will accrue approximately 300 patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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valrubicin
conventional surgery
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifiers for bladder cancer Chemotherapy: No prior or concurrent chemotherapy for bladder cancer No prior AD 32 therapy for bladder cancer Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy Surgery: At least 9 months since any complete transurethral resection of the bladder
18 Years
ALL
No
Sponsors
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Anthra Pharmaceuticals
INDUSTRY
Principal Investigators
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Peter R. Carroll, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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Urology Associates
Birmingham, Alabama, United States
Urology Associates, Ltd.
Phoenix, Arizona, United States
University of California San Diego Cancer Center
La Jolla, California, United States
San Diego Urology Center
La Mesa, California, United States
Hillcrest Urological Medical Group
San Diego, California, United States
San Diego Urology Center
San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Santa Monica Urologic Medical Group
Santa Monica, California, United States
Western Urological Associates
Van Nuys, California, United States
Urology Specialists, P.C.
Waterbury, Connecticut, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Atlantic Urological Associates
Daytona Beach, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Urology Care - South
Miami, Florida, United States
Urology Health Center
New Port Richey, Florida, United States
Office of Ira W. Klimberg
Ocala, Florida, United States
Urology Treatment Center
Sarasota, Florida, United States
Georgia Urology
Atlanta, Georgia, United States
Affliated Urology
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States
Clinic of Urologic Wellness
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Cambridge Urological Associates, Inc.
Cambridge, Massachusetts, United States
Michigan Institute of Urology
Detroit, Michigan, United States
Mississippi Urology Clinic, P.A.
Jackson, Mississippi, United States
Urology Center
Omaha, Nebraska, United States
Sheldon Freedman Ltd.
Las Vegas, Nevada, United States
Desert Urology
North Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Office of John Byrne
New Rochelle, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Wake Urological Associates
Raleigh, North Carolina, United States
Department of Urology and Urologic Oncology
Columbus, Ohio, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
Urology Clinic, P.C.
Portland, Oregon, United States
Office of Jeffrey K. Cohen
Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
Urology Associates of North Texas
Arlington, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Sentara Cancer Center
Norfolk, Virginia, United States
Virginia Urology Center
Richmond, Virginia, United States
Office of Ronald G. Anderson
Tacoma, Washington, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ANTHRA-A9601
Identifier Type: -
Identifier Source: secondary_id
CDR0000066837
Identifier Type: -
Identifier Source: org_study_id