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Home > "C" Clinical Trials Conditions > Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer  Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
For Condition: recurrent bladder cancer,stage 0 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B,Southwest Oncology Group
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidWood, Study Chair, Southwest Oncology Group
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36652
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79423
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Additional Information:
Study ID Numbers: CDR0000066978; SWOG-S9809
Study Start Date: April 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003824
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
2. Tipifarnib in Treating Patients With Recurrent Bladder Cancer
3. High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer
4. Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer
5. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
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