Bladder CancerPhase 3NCT00003824
S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
A Phase 3 study testing cephalexin, surgical procedure and Ciprofloxacin in people with Bladder Cancer, run by SWOG Cancer Research Network at 90 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- cephalexin, surgical procedure and Ciprofloxacin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 90 sitesUnited States
- Study dates
- Apr 1999to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
90 sites in 1 country.
90 sites in 1 country
United States90 sites
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
CCOP - Columbus
Columbus, Ohio, 43206
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
CCOP - Central Illinois
Decatur, Illinois, 62526
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
University of Colorado Cancer Center
Denver, Colorado, 80262
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of Texas Medical Branch
Galveston, Texas, 77555-0209
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
CCOP - Dayton
Kettering, Ohio, 45429
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
Texas Tech University Health Science Center
Lubbock, Texas, 79423
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153
MBCCOP - Gulf Coast
Mobile, Alabama, 36652
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Eastern Virginia Medical School
Norfolk, Virginia, 23507
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center
Orange, California, 92868
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Program
Portland, Oregon, 97213
University of California Davis Medical Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center
Tucson, Arizona, 85724
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder
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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- cephalexin, surgical procedure, Ciprofloxacin
- Keywords
- stage 0 bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalexinDrug
Also called antibiotic
500 mg oral bid for 3 days starting the night before resection
surgical procedureProcedure or surgery
CiprofloxacinDrug
Also called cipro
500 mg oral bid for 3 days starting the night before resection
| Study group | Role | What they receive |
|---|---|---|
| cipro | Experimental | ciprofloxacin Receives: Procedure: surgical procedure; Drug: Ciprofloxacin |
| ceph | Experimental | cephalexin Receives: Drug: cephalexin; Procedure: surgical procedure |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2004 (estimated)
- Study startApr 1999
- Primary completionJul 2001
- Study completionJan 2007
Why it stopped: Permanently Closed Due to Poor Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David P. Wood, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003824
- Sponsor's protocol ID
- CDR0000066978
- Other IDs
- S9809, U10CA032102
- Status last verified
- Mar 2012
- First submitted
- 1 Nov 1999
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolman SR, Goldman B, Slovak ML, Tangen C, Persons DL, Wood D. Aneusomy for detection of bladder cancer recurrence: a Southwest Oncology Group study. Cancer Genet Cytogenet. 2007 Jul 1;176(1):22-7. doi: 10.1016/j.cancergencyto.2007.02.015.
PubMed 17574960
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT00003824
- Acronym / sponsor ID
- CDR0000066978
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Permanently Closed Due to Poor Accrual
- Enrolment
- 114 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 14 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cipro | Experimental | Procedure: surgical procedure, Drug: Ciprofloxacinciprofloxacin |
| ceph | Experimental | Drug: cephalexin, Procedure: surgical procedurecephalexin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cephalexinAlso: antibiotic500 mg oral bid for 3 days starting the night before resection | Drug | ceph |
| surgical procedure | Procedure or surgery | ceph, cipro |
| CiprofloxacinAlso: cipro500 mg oral bid for 3 days starting the night before resection | Drug | cipro |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Permanently Closed Due to Poor Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Results publication: PubMed 17574960Wolman SR, Goldman B, Slovak ML, Tangen C, Persons DL, Wood D. Aneusomy for detection of bladder cancer recurrence: a Southwest Oncology Group study. Cancer Genet Cytogenet. 2007 Jul 1;176(1):22-7. doi: 10.1016/j.cancergencyto.2007.02.015.
Related trials for Bladder Cancer
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
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Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
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Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P. Wood, MD study chair
Barbara Ann Karmanos Cancer Institute
90 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cephalexin, surgical procedure and Ciprofloxacin in people with Bladder Cancer, run by SWOG Cancer Research Network at 90 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Permanently Closed Due to Poor Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.