S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Registration Number
- NCT00003824
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cipro surgical procedure ciprofloxacin ceph cephalexin cephalexin ceph surgical procedure cephalexin cipro Ciprofloxacin ciprofloxacin
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (90)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Dayton
🇺🇸Kettering, Ohio, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Beckman Research Institute, City of Hope
🇺🇸Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Center at Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States