Clinical trial NCT00003725: Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

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