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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003725
• Other study ID #: CDR0000066837
• Secondary ID: ANTHRA-A9601
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: December 1996

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• valrubicin

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Urology Associates of North Texas	Arlington	Texas
United States	Georgia Urology	Atlanta	Georgia
United States	Urology Associates	Birmingham	Alabama
United States	Cambridge Urological Associates, Inc.	Cambridge	Massachusetts
United States	Affliated Urology	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Department of Urology and Urologic Oncology	Columbus	Ohio
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	Michigan Institute of Urology	Detroit	Michigan
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Mississippi Urology Clinic, P.A.	Jackson	Mississippi
United States	University of California San Diego Cancer Center	La Jolla	California
United States	San Diego Urology Center	La Mesa	California
United States	Wilford Hall - 59th Medical Wing	Lackland Air Force Base	Texas
United States	Sheldon Freedman Ltd.	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Clinic of Urologic Wellness	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Urology Care - South	Miami	Florida
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	Urology Health Center	New Port Richey	Florida
United States	Office of John Byrne	New Rochelle	New York
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Sentara Cancer Center	Norfolk	Virginia
United States	Desert Urology	North Las Vegas	Nevada
United States	Office of Ira W. Klimberg	Ocala	Florida
United States	Urology Center	Omaha	Nebraska
United States	Urology Associates, Ltd.	Phoenix	Arizona
United States	Office of Jeffrey K. Cohen	Pittsburgh	Pennsylvania
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	Urology Clinic, P.C.	Portland	Oregon
United States	Wake Urological Associates	Raleigh	North Carolina
United States	Virginia Urology Center	Richmond	Virginia
United States	Huntsman Cancer Institute	Salt Lake City	Utah
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	Urology Treatment Center	Sarasota	Florida
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Office of Ronald G. Anderson	Tacoma	Washington
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	Western Urological Associates	Van Nuys	California
United States	George Washington University Hospital	Washington	District of Columbia
United States	Urology Specialists, P.C.	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Anthra Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,