S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

Last updated: March 7, 2012
Sponsor: Southwest Oncology Group
Overall Status: Terminated

Phase

3

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT00003824
CDR0000066978
S9809
U10CA032102
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 114
Study Start date:
April 01, 1999
Estimated Completion Date:
January 31, 2007

Study 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.

Connect with a study center

  • MBCCOP - Gulf Coast

    Mobile, Alabama 36652
    United States

    Site Not Available

  • CCOP - Greater Phoenix

    Phoenix, Arizona 85006-2726
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona 85723
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California 90822
    United States

    Site Not Available

  • Beckman Research Institute, City of Hope

    Los Angeles, California 91010
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033-0800
    United States

    Site Not Available

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California 94553
    United States

    Site Not Available

  • CCOP - Bay Area Tumor Institute

    Oakland, California 94609-3305
    United States

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California 94121
    United States

    Site Not Available

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California 95403
    United States

    Site Not Available

  • David Grant Medical Center

    Travis Air Force Base, California 94535
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado 80220
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia 30905-5650
    United States

    Site Not Available

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • CCOP - Central Illinois

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois 60141
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7357
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky 40536-0084
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky 40511-1093
    United States

    Site Not Available

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana 71130
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts 02130
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109-0752
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan 48201-1932
    United States

    Site Not Available

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Providence Hospital - Southfield

    Southfield, Michigan 48075-9975
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi 39531-2410
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216-4505
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Keesler Medical Center - Keesler AFB

    Keesler AFB, Mississippi 39534-2576
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • CCOP - St. Louis-Cape Girardeau

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St. Louis University Health Sciences Center

    Saint Louis, Missouri 63110-0250
    United States

    Site Not Available

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri 65807
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico 87108-5138
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York 11209
    United States

    Site Not Available

  • Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Site Not Available

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio 45220-2288
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43206
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio 45428
    United States

    Site Not Available

  • CCOP - Dayton

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • CCOP - Columbia River Program

    Portland, Oregon 97213
    United States

    Site Not Available

  • Oregon Cancer Center at Oregon Health Sciences University

    Portland, Oregon 97201-3098
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon 97207
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Simmons Cancer Center - Dallas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas 75216
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555-0209
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Lubbock, Texas 79423
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78284-7811
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas 78284
    United States

    Site Not Available

  • CCOP - Scott and White Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Temple

    Temple, Texas 76504
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah 84148
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington 98108
    United States

    Site Not Available

  • CCOP - Northwest

    Tacoma, Washington 98405-0986
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.