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
18 Years
N/A
Both
Bladder Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Peter R. Carroll, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000066837
NCT ID:
NCT00003725
Start Date:
December 1996
Completion Date:
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- recurrent bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
| Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
| George Washington University Hospital | Washington, District of Columbia 20037 |
| Urology Specialists, P.C. | Waterbury, Connecticut 06708 |
| University of Florida - Gainesville | Gainesville, Florida 32610-0277 |
| Urology Associates | Birmingham, Alabama 35205 |
| Urology Associates, Ltd. | Phoenix, Arizona 85012 |
| San Diego Urology Center | La Mesa, California 91942 |
| Hillcrest Urological Medical Group | San Diego, California 92103 |
| Santa Monica Urologic Medical Group | Santa Monica, California 90404 |
| Western Urological Associates | Van Nuys, California 91405 |
| Atlantic Urological Associates | Daytona Beach, Florida 32114 |
| Urology Care - South | Miami, Florida 33173 |
| Urology Health Center | New Port Richey, Florida 34652 |
| Office of Ira W. Klimberg | Ocala, Florida 32674 |
| Urology Treatment Center | Sarasota, Florida 3429 |
| Georgia Urology | Atlanta, Georgia 30342 |
| Affliated Urology | Chicago, Illinois 60612 |
| Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
| Clinic of Urologic Wellness | Lexington, Kentucky 40509 |
| Cambridge Urological Associates, Inc. | Cambridge, Massachusetts 02238 |
| Michigan Institute of Urology | Detroit, Michigan 48236 |
| Mississippi Urology Clinic, P.A. | Jackson, Mississippi 39202 |
| Urology Center | Omaha, Nebraska 68122 |
| Sheldon Freedman Ltd. | Las Vegas, Nevada 89109 |
| Desert Urology | North Las Vegas, Nevada 89128 |
| Office of John Byrne | New Rochelle, New York 10801 |
| Wake Urological Associates | Raleigh, North Carolina 27607 |
| Department of Urology and Urologic Oncology | Columbus, Ohio 43210 |
| Urology Clinic, P.C. | Portland, Oregon 97210 |
| Office of Jeffrey K. Cohen | Pittsburgh, Pennsylvania 15222 |
| Urology Associates of North Texas | Arlington, Texas 76015 |
| Sentara Cancer Center | Norfolk, Virginia 23507 |
| Virginia Urology Center | Richmond, Virginia 23230 |
| Office of Ronald G. Anderson | Tacoma, Washington 98405 |
