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The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder


OBJECTIVES: I. Determine whether ciprofloxacin improves the recurrence-free survival of
patients with superficial transitional cell carcinoma of the bladder treated with a
transurethral tumor resection.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status (first occurrence vs recurrent disease). Patients are randomized to receive
either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night
before resection. Patients who are allergic to penicillin or a cephalosporin receive oral
co-trimoxazole 2 times a day for 3 days. All patients undergo complete resection of all
bladder tumors. Patients are followed every 3 months for the first 2 years, every 6 months
for the next 2 years, and at the end of the fifth year.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Stage Ta (any grade) transitional cell carcinoma of the bladder
on basis of cystoscopy Recurrent disease no greater than T1 Must not be at high risk for
upper tract (ureter or renal pelvic) transitional cell cancers

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
prior malignancy in the past 5 years except adequately treated basal cell or squamous cell
skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer
in complete remission No allergies to fluoroquinolones If allergic to penicillin or
cephalosporin, must be able to take co-trimoxazole

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 28 days
since prior intravesical therapy and recovered Endocrine therapy: Not specified
Radiotherapy: At least 28 days since prior radiotherapy and recovered Surgery: Not
specified Other: At least 3 months prior to cystoscopy since prior fluoroquinolones No
concurrent fluoroquinolones No concurrent hemodialysis or peritoneal dialysis No
concurrent probenecid or theophylline No concurrent antacids containing aluminum,
magnesium or calcium, products containing iron or zinc, caffeine, cyclosporine, or
warfarin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David P. Wood, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066978

NCT ID:

NCT00003824

Start Date:

April 1999

Completion Date:

January 2007

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209