Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

November 5, 2013 updated by: Anthra Pharmaceuticals

Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors

RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder. II. Assess the toxicity of AD 32 in these patients.

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Urology Associates
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Urology Associates, Ltd.
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego Cancer Center
      • La Mesa, California, United States, 91942
        • San Diego Urology Center
      • San Diego, California, United States, 92103
        • Hillcrest Urological Medical Group
      • San Diego, California, United States, 92120
        • San Diego Urology Center
      • San Francisco, California, United States, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
      • Santa Monica, California, United States, 90404
        • Santa Monica Urologic Medical Group
      • Van Nuys, California, United States, 91405
        • Western Urological Associates
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Urology Specialists, P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Hospital
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Gainesville, Florida, United States, 32610-0277
        • University of Florida - Gainesville
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
      • Miami, Florida, United States, 33173
        • Urology Care - South
      • New Port Richey, Florida, United States, 34652
        • Urology Health Center
      • Ocala, Florida, United States, 32674
        • Office of Ira W. Klimberg
      • Sarasota, Florida, United States, 3429
        • Urology Treatment Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Urology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60612
        • Affliated Urology
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Clinic of Urologic Wellness
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02238
        • Cambridge Urological Associates, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Michigan Institute of Urology
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mississippi Urology Clinic, P.A.
    • Nebraska
      • Omaha, Nebraska, United States, 68122
        • Urology Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sheldon Freedman Ltd.
      • North Las Vegas, Nevada, United States, 89128
        • Desert Urology
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
    • New York
      • New Rochelle, New York, United States, 10801
        • Office of John Byrne
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Wake Urological Associates
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Department of Urology and Urologic Oncology
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Cancer Center at Oregon Health Sciences University
      • Portland, Oregon, United States, 97210
        • Urology Clinic, P.C.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15222
        • Office of Jeffrey K. Cohen
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt Cancer Center
    • Texas
      • Arlington, Texas, United States, 76015
        • Urology Associates of North Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Lackland Air Force Base, Texas, United States, 78236-5300
        • Wilford Hall - 59th Medical Wing
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Cancer Center
      • Richmond, Virginia, United States, 23230
        • Virginia Urology Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Office of Ronald G. Anderson
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9162
        • West Virginia University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically diagnosed stage 0 (Ta), stage I, or recurrent superficial transitional cell carcinoma of the bladder Must have at least 2 papillary appearing bladder tumors by cystoscopic examination Patients with recurrent disease must have no history of Tis tumor

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthra Pharmaceuticals

Investigators

  • Study Chair: Peter R. Carroll, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1996

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 21, 2004

First Posted (Estimate)

July 22, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066837
  • ANTHRA-A9601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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